Patient-related complications of pulsed-field ablation catheters: A FDA MAUDE database analysis of farawave system
O Makdah, C Ursu, M bistriceanu, G Teadorescu, B Moise, A carja, A khebbaiz, E Gales, S Bogdan, D MusatAbstract
Introduction
Pulsed-field ablation (PFA) is a novel energy source that induces selective and irreversible electroporation of cardiomyocytes without collateral damage to surrounding tissues. Post-marketing safety comparisons between commercially available PFA platforms remain limited.
Objective
To analyze device- and patient-related complications with the Farawave PFA catheters using the FDA MAUDE database.
Methods
The FDA MAUDE database was queried for adverse events of commercial PFA catheters from January 1 to December 31, 2024. Reports were identified by manufacturer and FDA product codes and categorized as device malfunctions, patient injuries, or deaths. We grouped the events into categories: circulatory, neurologic, arrhythmia, life-threatening,catheter-related and others. We reported the data descriptively using total event counts and percentages.
Results
A total of 1480 adverse event reports related to the Farawave catheter were identified. Circulatory complications were the most frequently reported category (n = 325; 21.96%), followed by neurologic events (n = 114; 7.70%) and arrhythmic events (n = 112; 7.57%). Catheter-related complications accounted for 47 reports (3.18%), while death was reported in 23 cases (2.02%). Life-threatening events represented 25 reports (1.69%), and other organ damage was documented in 17 cases (1.15%). Within the circulatory category, pericardial effusion was the predominant event (n = 91; 28.00% of circulatory events), followed by cardiac tamponade (n = 41; 12.62%) and cardiac perforation (n = 26; 8.00%). Among neurologic complications, stroke was the most commonly reported event (n = 23; 20.18% of neurologic events), whereas transient ischemic attack accounted for 5 cases (4.39%). Regarding arrhythmic complications, ventricular fibrillation was reported in 7 cases (28.00% of arrhythmic events), and asystole in 2 cases (8.00%). Within life-threatening events, cardiac arrest represented 16 cases (64.00%). Among catheter-related complications, hemolysis was the most frequently reported event (n = 19; 40.43%).
Conclusion
Overall, circulatory complications particularly pericardial effusion and cardiac tamponade, constituted the largest proportion of reported adverse events associated with the Farawave catheter.Complications