MAUDE Adverse Event Report: ABBOTT MEDICAL CURRENT¿ PFA GENERATOR; NO MATCH

Model Number	PFA-GEN-01
Medical Device Problem Codes	Fire (1245); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, after finishing ablation of the left pulmonary veins and about to reach for the right pulmonary veins, a loud bang was heard and a flame and sparks were observed from the footswitch port.A message was noted, "pfa generator fault.Hardware issue detected.Select restart to restart the pfa generator." the procedure was changed to rf to complete the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One pulse field ablation (pfa) generator was received for evaluation.Visual inspection revealed that the front ports, rear ports, and chassis exhibited wear consistent with normal use over time.The unit was powered on; however, the generator failed to pass the power-on self-test (post).A hardware 101 error was displayed, and system logs could not be retrieved.Disassembly of the device identified evidence of electrical thermal damage to the bfc pinnacle hv board and the hv bridge board located in slot 1.The reported field event was confirmed through visual inspection findings.Although the issue could not be reproduced during functional testing, the root cause was attributed to electrical thermal damage to the bfc pinnacle hv board and the hv bridge board in slot 1.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: CURRENT¿ PFA GENERATOR
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24541763
• Report Number: 2184149-2026-00062
• Device Sequence Number: 16041178
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11016801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P250022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFA-GEN-01
• Device Catalogue Number: PFA-GEN-01
• Device Lot Number: 11016801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/08/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown