Device- and patient-related complications of pulsed-field ablation catheters: a FDA MAUDE database analysis comparing PULSESELCT and VARIPULSE
O Makdah, C Ursu, M Bistriceanu, G Teodorescu, B Moise, A Carja, A khebbaiz, E Gales, A Musat, A Florescu, 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 compare device- and patient-related complications with the PULSESELCT and VARIPULSE PFA catheters using the FDA MAUDE database.
Methods
The FDA MAUDE database was searched for adverse events associated with commercial PFA catheters from January 1, 2024, to June 1, 2025. Reports were classified by manufacturer and FDA product codes and grouped into device malfunctions, patient injuries, or deaths. Disproportionality analysis was conducted using reporting odds ratios (ROR) with 95% confidence intervals (CI).
Results
A total of 103 events were reported with Varipulse and 326 were reported with PulseSelect. No significant differences were observed between PulseSelect and Varipulse for arrhythmic (8 vs 4; ROR 0.71, 95% CI 0.21–2.43), life-threatening (7 vs 5; ROR 0.49, 95% CI 0.15–1.59), or other organ damage complications (10 vs 8; ROR 0.43, 95% CI 0.16–1.12). In contrast, circulatory complications (19 vs 17; ROR 0.36, 95% CI 0.18–0.72) and neurologic complications (17 vs 50; ROR 0.06, 95% CI 0.03–0.12) were significantly less frequently reported with PulseSelect compared to Varipulse. Disproportionality analysis demonstrated significantly higher reporting odds with Varipulse for post-insertion device-related events (19 vs 31; ROR 2.15, 95% CI 1.16–4.00) and events classified as “other” (70 vs 42 ROR; 14.34, 95% CI 8.48–24.26). In contrast, manufacturing issues (4 vs 266; ROR 0.01, 95% CI 0.00–0.03) and software/interface problems (6 vs 11; ROR 0.12, 95% CI 0.04–0.32) were disproportionately reported with PulseSelect. No significant difference was observed for issues identified during pre-insertion (19 vs 31; ROR 0.44, 95% CI 0.10–1.97).
Conclusion
In this analysis PulseSelect and Varipulse showed comparable reporting rates for arrhythmic, life-threatening, and other organ complications. However, PulseSelect was associated with significantly lower reporting odds of circulatory and neurologic events compared with Varipulse. Varipulse was associated with more post-insertion device events, whereas PulseSelect showed more manufacturing and software-related issues.These findings suggest potential differences in safety profiles that warrant further investigation in prospective studies.Device relatedPatient related