Complications and Failure Modes of Polymer-Jacketed Guidewires; Insights From the MAUDE Database

Background: The modes of failure of coronary polymer-jacketed guidewires have received limited study. Methods: We queried the 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 as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection). 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 common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires.