Key result
Farawave pulsed-field ablation adverse events most commonly involve circulatory complications at ~22%.
Why the study?
Post-marketing safety data for commercially available pulsed-field ablation platforms remain limited, motivating an analysis of device- and patient-related complications with the Farawave PFA catheter.
Observational (n=1,480)
Post-marketing surveillance from the FDA MAUDE database reveals that circulatory complications, particularly pericardial effusion and cardiac tamponade, represent the largest proportion of reported adverse events associated with the Farawave pulsed-field ablation catheter.
Monitor for circulatory complications with Farawave; leaves open prospective trials to quantify true risks in pulsed-field ablation.
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
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Makdah et al. (2026) conducted an observational in Adverse events related to pulsed-field ablation (Farawave catheter) (n=1,480). Farawave pulsed-field ablation catheter was evaluated on Device- and patient-related complications (most frequently circulatory complications). Farawave pulsed-field ablation catheter adverse event reports (n=1,480) most commonly involved circulatory complications (21.96%), neurologic events (7.70%), and arrhythmias (7.57%).
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