Device- and patient-related complications of pulsed-field ablation catheters: a FDA MAUDE database analysis comparing FARAWAVE and VARIPULSE
O Makdah, C Ursu, M Bistriceanu, G Teodorescu, A carja, B Moise, A Khebbaiz, E Gales, A Musat, A florescu, B Stefan, 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 FARAWAVE 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 1,480 events were reported for Farawave and 95 for Varipulse. Circulatory complications were more frequent with Varipulse (325 vs 17; ROR 1.41, 95% CI 0.83 – 2.41), and the neurologic complications (114 vs 50; ROR 0.09, 95% CI 0.06 – 0.14). Arrhythmias (112 vs 4; ROR 2.01, 95% CI 0.73 – 5.58) were similar. Life-threatening events were similar (25 vs 2; ROR 0.86, 95% CI 0.20 – 3.69). Varipulse reported more other organ damage (17 vs 4; ROR 0.29, 95% CI 0.09 – 0.87). Regarding device complications, 1488 in Farawave and 103 in Varipulse were reported. Farawave was associated with significantly higher reporting odds for manufacturing-related issues (292 vs 4; ROR 6.04, 95% CI 2.21–16.55) and defects identified during pre-insertion (122 vs 2; ROR 4.51, 95% CI 1.10–18.51). Post-insertion device-related events were also more frequently reported with Farawave (670 vs 22; ROR 3.02, 95% CI 1.86–4.88). Conversely, software/interface problems were disproportionately reported with Varipulse (26 vs 6; ROR 0.30, 95% CI 0.12–0.75 relative to Farawave). Other device-related complications were less frequently reported with Farawave (377 vs 70; ROR 0.16, 95% CI 0.10–0.25)
Conclusion
In this analysis, Varipulse was more frequently associated with circulatory and other organ complications, while neurologic events differed between systems. No significant differences were observed in arrhythmias or life-threatening events. Farawave was more often associated with manufacturing and post-insertion device issues, whereas Varipulse had more software-related and certain clinical complications. These differences suggest distinct safety profiles that should be evaluated in further studies.FARAWAVE and VARIPULSE Patient relatedFARAWAVE and VARIPULSE Device related