Why the study?
To characterize individual-case medical device reports submitted to the FDA MAUDE database for commercially available pulsed-field ablation systems during early postmarket use.
Population
10,976 individual-case medical device reports from the FDA MAUDE database
Design
Post-market surveillance database analysis
Key result
Among 10,976 FDA MAUDE reports for pulsed-field ablation, 66.7% involved device malfunction without patient injury and 32.4% involved patient injury.
Authors
Loading...
MAUDE reports associate pulsed-field ablation with malfunctions and injuries; hypothesis-generating for prospective safety registries.
Observational (n=10,976)
Early post-market surveillance of pulsed-field ablation systems in the FDA MAUDE database identifies device malfunctions and specific clinical adverse events, highlighting priorities for future prospective registries.
Gu et al. (2026) conducted an observational in Atrial fibrillation (n=10,976). Pulsed-field ablation was evaluated on Reporting phenotypes and clinical event categories. Among 10,976 FDA MAUDE reports for pulsed-field ablation, 66.7% involved device malfunction without patient injury and 32.4% involved patient injury.