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.