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Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database
Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database
- Source :
- Cardiovascular Revascularization Medicine. 20:507-512
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- Background/purpose Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use. Methods/materials The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed. Results Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported. Conclusions Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.
- Subjects :
- Percutaneous
Databases, Factual
medicine.medical_treatment
Coronary Artery Disease
030204 cardiovascular system & hematology
computer.software_genre
Cardiac Catheters
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Optical coherence tomography
Predictive Value of Tests
Risk Factors
medicine
Humans
030212 general & internal medicine
Adverse effect
Retrospective Studies
Modality (human–computer interaction)
Database
medicine.diagnostic_test
Event (computing)
business.industry
Percutaneous coronary intervention
Equipment Design
General Medicine
Coronary Vessels
Coronary arteries
Catheter
medicine.anatomical_structure
Equipment Failure
Stents
Cardiology and Cardiovascular Medicine
business
computer
Tomography, Optical Coherence
Subjects
Details
- ISSN :
- 15538389
- Volume :
- 20
- Database :
- OpenAIRE
- Journal :
- Cardiovascular Revascularization Medicine
- Accession number :
- edsair.doi.dedup.....67ca8c2b7a57d505aa62adcc93fcf85e
- Full Text :
- https://doi.org/10.1016/j.carrev.2019.03.009