Complications and failure modes of polymer-jacketed guidewires; insights from the MAUDE database.

Abstract Background The modes of failure of coronary polymer-jacketed guidewires are seldom studied in a systematic fashion. Methods We queried Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports. Results The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff guidewires (45.2% vs. 14.6% and 21.4% vs. 5.3%, respectively). Conclusions The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more reported with the stiff polymer-jacketed guidewires and wire fracture was more reported with soft guidewires.