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Introduction: Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared. Materials and Methods: Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken. Results: Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (P =<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting (P = 0.003) and angioplasty with stenting (P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure (P = 0.005). Conclusion: Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Hemostatic devices are now frequently used in femoral artery punctures, and the Angio-Seal (Terumo, Tokyo, Japan) is one of the most commonly used devices for closure of the femoral artery because it provides rapid hemostasis. Although device failure rarely occurs, if the collagen falls into the femoral artery, it may lead to severe limb ischemia. Herein, we describe a case of a novel endovascular technique for the treatment of Angio-Seal arterial closure device failure. Case presentation: The patient in Case 1 was a 75-year-old man with severe left limb claudication. We used a contralateral antegrade approach and used the Angio-Seal for hemostasis. However, the Angio-Seal collagen and footplate dropped and stopped at the bifurcation of the superficial femoral artery and deep femoral artery. The collagen with the footplate was caught with myocardial biotome forceps (MBF) and pulled into the external iliac artery (EIA). The distal common femoral artery (CFA) was punctured, and we delivered a 10.0- × 80-mm stent (SMART®; Cordis, USA) to the EIA from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen. The patient in Case 2 was an 88-year-old man with rest pain in the right limb. The right CFA was punctured using an ipsilateral approach and the Angio-Seal was used for hemostasis. The Angio-Seal collagen with the footplate dropped into the bifurcation of the deep femoral artery. The collagen and footplate were caught with MBF and pulled up to the EIA. The right CFA was punctured and a 10.0- × 60-mm stent (SMART®; Cordis) was delivered from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen with the footplate. Conclusions: MBF were used to grasp the dislodged collagen with the anchor and cover it with a stent at the iliac artery. This may be a useful bailout technique for Angio-Seal dislodgement. [ABSTRACT FROM AUTHOR]

Abstract Background Hemostatic devices are now frequently used in femoral artery punctures, and the Angio-Seal (Terumo, Tokyo, Japan) is one of the most commonly used devices for closure of the femoral artery because it provides rapid hemostasis. Although device failure rarely occurs, if the collagen falls into the femoral artery, it may lead to severe limb ischemia. Herein, we describe a case of a novel endovascular technique for the treatment of Angio-Seal arterial closure device failure. Case presentation The patient in Case 1 was a 75-year-old man with severe left limb claudication. We used a contralateral antegrade approach and used the Angio-Seal for hemostasis. However, the Angio-Seal collagen and footplate dropped and stopped at the bifurcation of the superficial femoral artery and deep femoral artery. The collagen with the footplate was caught with myocardial biotome forceps (MBF) and pulled into the external iliac artery (EIA). The distal common femoral artery (CFA) was punctured, and we delivered a 10.0- × 80-mm stent (SMART®; Cordis, USA) to the EIA from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen. The patient in Case 2 was an 88-year-old man with rest pain in the right limb. The right CFA was punctured using an ipsilateral approach and the Angio-Seal was used for hemostasis. The Angio-Seal collagen with the footplate dropped into the bifurcation of the deep femoral artery. The collagen and footplate were caught with MBF and pulled up to the EIA. The right CFA was punctured and a 10.0- × 60-mm stent (SMART®; Cordis) was delivered from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen with the footplate. Conclusions MBF were used to grasp the dislodged collagen with the anchor and cover it with a stent at the iliac artery. This may be a useful bailout technique for Angio-Seal dislodgement.

Objective: Puncture site complications in neuro-endovascular therapy, which represent a significant cause of morbidity, are often difficult to treat. Vascular closure devices have evolved in endovascular therapy. We analyzed risk factors for puncture site complications and examined the efficacy of hemostasis methods in neuro-endovascular therapy. Methods: This retrospective, observational, single-center study was conducted from January 2021 to January 2023. We enrolled 202 puncture sites of patients who underwent neuro-endovascular therapy at Kawaguchi Municipal Medical Center and analyzed the complications requiring additional intervention. Results: There were 12 (5.94 %) puncture site complications. No patient had permanent puncture-related complications. Univariate analyses revealed that a higher risk of puncture site complications was significantly associated with multiple antiplatelet agents (p = 0.03), hypertension (p = 0.03), scheduled treatment (p

Vascular closure devices (VCD) are frequently used after endovascular interventions to attain faster hemostasis, earlier mobilization, and patient comfort compared to manual compression. VCDs are safe. However, rare complications have been reported. We report a case of an inadvertent intravascular deployment of an Angio-Seal VCD causing limb ischemia and discussing management options from our experience and the previously published cases.

Vascular closure devices (VCDs) are being increasingly used for achieving hemostasis after diagnostic and therapeutic endovascular procedures. Although uncommon, complications may be encountered which are associated with the use of these VCDs. We report four cases where the use of Angio-Seal (Terumo, Somerset, New Jersey, USA) was followed by complications. Three cases presented with acute limb ischemia, among them, two patients had arterial occlusion at the vascular access site and one patient had embolization of the footplate anchor of the closure device. One case presented with pseudoaneurysm at the common femoral artery access site along with occlusion at origin of the superficial femoral artery. We have described the mechanism in which these complications occur and the successful management of these cases preventing potential amputation and limb loss. Te risk factors which increase the risk of complications with the use of Angio-Seal VCD were reviewed and the strategy to avoid these complications with particular emphasis on the utility of ultrasound when using Angio-Seal VCD is discussed. A strategy to manage these complications has been discussed while deciding on endovascular management or surgical management, especially in patients with challenging presentation and those with multiple comorbidities making them at very high risk for surgery. [ABSTRACT FROM AUTHOR]

Vascular closure devices (VCD) are frequently used after endovascular interventions to attain faster hemostasis, earlier mobilization, and patient comfort compared to manual compression. VCDs are safe. However, rare complications have been reported. We report a case of an inadvertent intravascular deployment of an Angio-Seal VCD causing limb ischemia and discussing management options from our experience and the previously published cases. [ABSTRACT FROM AUTHOR]

Purpose: Pseudoaneurysm (PSA) developing after catheter examinations is one of the most frequent vascular complications and a nonsurgical technique with utmost low risk of complications is warranted. Our aim was to investigate the technical feasibility, success, and safety of transaneurysmal occlusion of complicated post-interventional common femoral artery (CFA) PSA using the Angio-Seal Closure Device (ASCD) and a technique that we describe as the transaneurysmal (TA) maneuver. Material and Methods: We used the Angio-Seal (Terumo, Tokyo, Japan) Closure System to manage complicated PSAs in patients who would otherwise have needed surgery after failure of all conservative therapies. The TA maneuver was performed in 14 consecutive patients from July 2021 to July 2022. After ultrasound-guided puncture of the PSA close to its neck, the CFA was entered radiographically with micro-guidewires, and the neck of the PSA was closed with the ASCD after changing the sheaths and wires. All patient had to wear a pressure dressing until the next day, when successful closure was verified by sonography. Results: All procedures were performed with technical success and without any complications. No patient had to undergo surgery. All sonographies on the next day confirmed complete absence of perfusion within the PSA and normal flow conditions of the CFA and vessels below. Conclusion: The TA maneuver a promising minimally invasive procedure for closing complicated PSA of the CFA after catheter examination. [ABSTRACT FROM AUTHOR]

Amaç: Bu çalışmada, köprüleyici intravenöz trombolitik tedavi uygulanıp ardından mekanik trombektomi (MT) prosedürü uygulanan hastalarda, femoral arter giriş yerinin, Angio-Seal Vasküler Kapatma Cihazı kullanılarak kapatılmasının etkinliğini ve güvenirliğini değerlendirilmesi amaçlanmıştır.. Gereç ve Yöntem: Bu retrospektif, gözlemsel çalışma, Eylül 2018- Eylül 2021 tarihleri arasında akut iskemik inme nedeniyle başvurmuş, köprüleyici tPA (doku plazminojen aktivatörü) sonrasında mekanik trombektomi işlemi gerçekleştirilmiş ve femoral arter giriş yerleri Angio-Seal ile kapatılan toplam 97 hasta çalışmaya dahil edilerek gerçekleştirilmiştir. Temel demografik veriler, eşlik eden risk faktörleri, major ve minör komplikasyon oranlarının, kategorik değişkenlere ait frekans dağılımları ile nicel verilere ait tanımlayıcı istatistikler hesaplanarak kaydedilmiştir. Bulgular: Hastaların %96,9'unda major komplikasyon ve %97,9'unda minör komplikasyon olmadığı bulunmuştur. Tüm hastalarda kasık bölgesinde başarılı hemostaz sağlanmıştır. Major komplikasyonlar, 1 (%1) psödo-anevrizma, 1 (%1) kasık girim bölgesinde enfeksiyon, 1 (%1) Angio-Seal yerleştirmede başarısızlık olarak kaydedilmiştir. 6 Fr (French) Angio-Seal kullanılanlarda %98,2’sinde ve 8 Fr Angio-Seal kullanılanların %95,1’inde majör komplikasyon görülmemiştir. Sonuç: Köprüleyici tPA kullanılan ve MT işlemi gerçekleştirilen akut iskemik inmeli hastalarda, kasık hemostazının sağlanmasında Angio-Seal kullanımı, geniş çaplı arteriotomilerde dahil olmak üzere etkili ve güvenli bir yöntemdir.

Background: The use of vascular closure devices (VCDs) to achieve quick and safe hemostasis after femoral arterial access is widely accepted. Major complications include bleeding and occlusion of the femoral artery due to device failure, which often necessitates vascular intervention. This manuscript details our peripheral percutaneous endovascular interventional (PEI) approach for the management of femoral artery occlusion resulting from Angio-Seal (Terumo, Somerset, New Jersey, USA) VCD deployment., Methods: Consecutive patients who developed occlusive complications after Angio-Seal deployment underwent PEI to overcome specific complications. Patients' clinical and procedural characteristics, along with their short- and long-term follow-up data, were analyzed., Results: The study cohort included 40 patients who experienced Angio-Seal occlusive complications between July 2013 and September 2023. The mean age of the patients was 74 ± 10 years and 55% were female. All the patients were treated with PEI, with an overall procedural success rate of 100%. The primary approach for PEI was directional atherectomy, which was used in 35 cases (88%), followed by balloon, while a cutting balloon was used in 5 patients (13%). Stenting served as the definitive therapy in only 7 patients (18%). No procedural complications or conversions to surgery were observed. During a median follow-up of 244 (IQR = 100-707) days, none of the patients required re-intervention related to Angio-Seal occlusion and salvage intervention., Conclusion: In the management of Angi-Seal VCD-related femoral artery occlusion, the adjunctive use of directional atherectomy followed by balloon angioplasty was effective and safe, allowing re-establishment of flow with excellent long-term outcomes., (© 2024 Wiley Periodicals LLC.)

Simple Summary: Endovascular surgery is a type of image-guided minimally invasive surgery that aims to solve different types of pathologies from inside the blood vessel. This technique requires access to a peripheral vessel (vein or artery) and the navigation through the vascular system to reach the operating site, using different catheters. In horses, the main indication for endovascular therapy involves access to the common carotid artery for different purposes. Traditionally, this was performed by open dissection of the neck to reach and incise the common carotid artery, followed by vascular suture of the vessel and skin closure when the procedure was over. However, this can also be performed by percutaneous puncture of the artery, using ultrasound to guide the needle to its adequate position in the artery, as has been reported in experimental horses. Along with that, in human medicine, commercial closure systems are used to seal these arterial punctures and avoid some complications (mainly haematomas and haemorrhages). We describe our experience in a series of 11 clinical cases in which this minimally invasive way of access was used, and the puncture site was sealed with one of these devices (AngioSeal arterial closure system), reporting its first use in horses. In all cases, the artery was effectively accessed, and the planned procedure could be performed. Our haematoma/bleeding rate (16.66%) was lower than in other studies using the same type of access, even considering two failures due to incorrect use of the device. However, further studies comparing AngioSeal use to simple manual compression would be necessary to be able to recommend their routine use in horses. Background: There are different indications for endovascular surgery in horses, mainly the treatment of guttural pouch mycosis. Traditionally, these procedures are carried out by open arteriotomy of the common carotid artery (CCA), although less invasive percutaneous ultrasound-guided carotid access (PUGCA) has been described in experimental horses. In human medicine, commercial closure systems are used to seal these arterial puncture sites and reduce complications. The aims of this study are to retrospectively describe our experience with PUGCA in clinical cases and to report, for the first time, the use of the commercial vascular closure device Angio-Seal after PUGCA in horses. Methods: Retrospective study of clinical case records. Collected parameters, including the feasibility of the PUGCA and variables related to the safety and efficacy of the use of the Angio-Seal. Results: Twelve PUGCA procedures in 11 horses were included. In all cases, the artery was effectively accessed, and the planned procedure could be performed. In two cases, haematoma/bleeding due to incorrect use of the Angio-Seal was recorded. This complication rate (16.66%) was lower than that obtained in other studies using PUGCA in horses, but where the puncture was sealed by manual compression only. Main limitations: A control group of clinical cases with PUGCA but without using Angio-Seal is not available. Conclusions: Clinical data confirm previous experimental results, which showed that PUGCA is safe and effective in horses. The Angio-Seal system, regardless of possible complications due to incorrect use, can be used safely and effectively in horses. Further studies comparing arterial access site management using manual compression or Angio-Seal would be necessary to state if its routine use in horses is advisable. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to evaluate the efficacy and safety of closure of the femoral artery access site using the Angio-Seal Vascular Closure Device in patients who underwent bridging intravenous thrombolytic therapy and subsequent mechanical thrombectomy (MT). Materials and Methods: The retrospective, observational study was performed in patients who were diagnosed with acute ischemic stroke and treated with MT after bridging IVT between September 2018 and September 2021. A total of 97 patients whose femoral artery access sites were closed with Angio-Seal after the procedure was performed were included in the study. Primary demographic data, accompanying risk factors, major and minor complication rates, frequency distributions of categorical variables, and descriptive statistics of quantitative data were calculated and recorded. Results: It was found that 96.9% of the patients did not have major complications, where 97.9% did not have minor complications either. Successful hemostasis was achieved in the groin region in all patients. Major complications observed were recorded as follows: 1 (1%) pseudo-aneurysm, 1 (%) inguinal incision site infection, and 1 (1%) Angio-Seal placement failure. No major complications were observed in 98.2% of those using 6 Fr (French) Angio-Seal and 95.1% of those using 8 Fr AngioSeal. Conclusion: The findings of the study indicate that Angio-Seal is an effective and safe method for providing groin hemostasis in patients with acute ischemic stroke. [ABSTRACT FROM AUTHOR]

Purpose: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis., Results: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days., Conclusions: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions., Clinical Impact: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Vascular complications (VCs) remain an important source of morbidity and mortality following percutaneous arterial catheterization. Vascular closure devices are popular and frequently used, but sometimes cause vessel occlusions that may require vascular surgery or complex endovascular procedures. In this case report, we describe the endovascular retrieval of an embolized Angio‐Seal device causing acute limb ischemia in a severely diseased 75‐year‐old female patient. This case highlights the endovascular technique using a snare catheter and adds another example to the growing evidence of an endovascular approach to manage vascular access site complications in comorbid patients at risk. [ABSTRACT FROM AUTHOR]

Abstract Vascular complications (VCs) remain an important source of morbidity and mortality following percutaneous arterial catheterization. Vascular closure devices are popular and frequently used, but sometimes cause vessel occlusions that may require vascular surgery or complex endovascular procedures. In this case report, we describe the endovascular retrieval of an embolized Angio‐Seal device causing acute limb ischemia in a severely diseased 75‐year‐old female patient. This case highlights the endovascular technique using a snare catheter and adds another example to the growing evidence of an endovascular approach to manage vascular access site complications in comorbid patients at risk.

Background: There are different indications for endovascular surgery in horses, mainly the treatment of guttural pouch mycosis. Traditionally, these procedures are carried out by open arteriotomy of the common carotid artery (CCA), although less invasive percutaneous ultrasound-guided carotid access (PUGCA) has been described in experimental horses. In human medicine, commercial closure systems are used to seal these arterial puncture sites and reduce complications. The aims of this study are to retrospectively describe our experience with PUGCA in clinical cases and to report, for the first time, the use of the commercial vascular closure device Angio-Seal after PUGCA in horses. Methods: Retrospective study of clinical case records. Collected parameters, including the feasibility of the PUGCA and variables related to the safety and efficacy of the use of the Angio-Seal. Results: Twelve PUGCA procedures in 11 horses were included. In all cases, the artery was effectively accessed, and the planned procedure could be performed. In two cases, haematoma/bleeding due to incorrect use of the Angio-Seal was recorded. This complication rate (16.66%) was lower than that obtained in other studies using PUGCA in horses, but where the puncture was sealed by manual compression only. Main limitations: A control group of clinical cases with PUGCA but without using Angio-Seal is not available. Conclusions: Clinical data confirm previous experimental results, which showed that PUGCA is safe and effective in horses. The Angio-Seal system, regardless of possible complications due to incorrect use, can be used safely and effectively in horses. Further studies comparing arterial access site management using manual compression or Angio-Seal would be necessary to state if its routine use in horses is advisable.

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized., Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria., Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD., Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR., (© 2024 Society for Cardiovascular Angiography and Interventions Foundation. Published by Elsevier Inc.)

Purpose: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed., Materials and Methods: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system., Results: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%)., Conclusions: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered., Clinical Impact: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.