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	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One current pfa generator was received for evaluation.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.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed, and no non-conformances associated with the reported event were identified.
Event or Problem Description
During a pfa procedure, a "noise" was heard from the current pfa generator and a message "volt generator hardware error.Please reboot" was displayed on the ensite system.Troubleshooting included multiple reboots of the generator with and without devices or cables connected, as well as trying different power outlets, but the issue persisted.It was noted that the standby button was not on during bootup.The issue could not be resolved and the procedure was cancelled.There were no adverse consequences for the patient.

• 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: 25448770
• Report Number: 2184149-2026-00173
• Device Sequence Number: 9510516
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11150476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 11150476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2026
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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