MAUDE Adverse Event Report: ABBOTT MEDICAL CURRENT¿ PFA GENERATOR; No Match

Model Number	PFA-GEN-01
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation pfa procedure, on the 17th pfa application, the current pfa generator produced a loud popping sound, and a hardware error appeared on the monitor.The system prompted us to restart the computer.However, after restarting, a case could not be started, and the system continuously prompted us to reboot.Even after disconnecting all cables, and rebooting the system again, the issue persisted.Physician decided to end the procedure and re-do if the arrhythmia recur.
Additional Manufacturer Narrative
One pfa generator was returned for investigation.The pfa was powered on, but the generator did not pass the power-on self-test (post).The pinnacle logs identified a ¿no current¿, a ¿high impedance¿ and an ¿ec wrong polarity¿ condition.The generator was disassembled and internally inspected.The bfc pinnacle board was found to have signs of damage to resistors r13, r14, r17, r19, r21, and r24.Further investigation identified thermal damage on pinnacle bridge board slot 2, specifically at and around locations c48, c49, c50, and c51.The field reported event was able to be confirmed by visual inspection.Based on the information provided to abbott and the investigation performed, the reported event was not able to be reproduced, however the root cause was attributed to electrical thermal damage to the bfc pinnacle hv board and the pinnacle bridge board.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformance's 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25187208
• Report Number: 2184149-2026-00147
• Device Sequence Number: 10693132
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)10971206
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 05/15/2026

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: 10971206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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