Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database
Highlights
- • MAUDE database was queried for all event reports involving coronary OCT devices.
- • Two independent reviewers identified 49 device reports included in final analysis.
- • 6.1% involved malfunction prior to insertion of the OCT catheter.
- • 30.6% did not result in an associated patient-related adverse event.
- • Users should be aware of optimal techniques to minimize adverse events.
Abstract
Background/purpose
Optical coherence tomography (OCT) is a high-resolution intravascular imagingmodality 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.