Adverse Events and Modes of Failure of Thermocool and Arctic Ablation Catheter: Insights from the FDA MAUDE Database.

Background: Arctic Front™ and Thermocool® ablation catheters have proven to be safe in clinical trials; real-world data on modes of failure and the complications of these devices are limited. Objectives: To assess the reported mechanisms of failure, clinical consequences, and outcomes among the most frequently used ablation catheters in the United States. Methods: Retrospective analysis of data from the FDA Manufacturer and User Facility Device Experience (MAUDE) registry in the last decade. Results: A total of 2092 reports were found during the study period. 1588 reports were included in the final analysis (Thermocool n=1016, Arctic Front n=572). The most commonly reported mode of failure was fracture of catheter component (i.e., guidewire, pebax, Balloon connector, shaft, tip, or bowden) 20.0% overall (13.9% with Thermocool and 30.8% with Arctic Front). Cardiac tamponade was the most common reported complication 23.4% overall (23.4% with Thermocool and 0% with Arctic Front). The procedure was aborted in 11.3% of the reported cases (16.2% with Thermocool and 2.6% with Arctic Front) with the need for surgical conversion in 7.9% overall (12.3 % with Thermocool and 0% with Arctic Front). The death occurred in 2.4% overall (3.7% with Thermocool and 0% with Arctic Front). Conclusions: The most reported mode of failure is the fracture of the catheter component, followed by the Kink of the catheter. The mostreported complications were cardiac tamponade and hemodynamic compromise; however, Arctic Front seems to be safe. Future efforts should focus on an innovative guidewire structure. [ABSTRACT FROM AUTHOR]