Post-market individual-report phenotypes after pulsed-field ablation for atrial fibrillation in a food and drug administration database.

PURPOSE: To characterize individual-case medical device reports submitted to the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database for commercially available pulsed-field ablation systems during early postmarket use.

METHODS

We analyzed reports received from February 1, 2024, through April 30, 2026. Master event, device, patient, patient problem code, device problem code, and narrative files were merged by report key. Literature-derived, clinical study-derived, false-positive, indeterminate, and exact duplicate narrative reports were excluded from the primary individual-case cohort. A prespecified hierarchy and targeted narrative review classified reporting phenotypes, reported clinical event categories, and device problem code categories. Duplicate-removal sensitivity analyses were performed.

RESULTS

Of 11,563 potential reports, 10,976 individual-case reports formed the primary cohort. Device malfunction without identified patient injury accounted for 7,323 reports (66.7%), patient injury for 3,554 (32.4%), and unclear/no coded clinical event for 99 (0.9%). The most commonly reported clinical event categories were tamponade/perforation/pericardial effusion (n = 1,014), arrhythmia/cardioversion/hemodynamic events (n = 444), stroke/TIA/neurovascular events (n = 383), coronary spasm/injury/ischemia (n = 324), death (n = 197), hemolysis/renal injury (n = 114), phrenic/diaphragm injury (n = 42), and plausible esophageal or upper gastrointestinal concerns (n = 6). Duplicate removal did not materially change the report-category hierarchy.

CONCLUSIONS

The value of this report-level surveillance analysis is characterization of report and event categories rather than incidence estimation. Future pulsed-field ablation registries should capture anticoagulation-related variables, patient-reported outcomes, lesion set and application burden, and adjudicated neurologic, coronary, renal, esophageal, and phrenic outcomes. PFA MAUDE reports identify electroporation-and workflow-relevant surveillance domains that should be prospectively captured, including anticoagulation variables, patient-reported outcomes, lesion set, application burden, and adjudicated clinical outcomes.