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

Model Number	PFA-GEN-01
Medical Device Problem Codes	Signal Artifact/Noise (1036); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulsed field ablation atrial fibrillation procedure, there was a procedural delay due to a generator issue.When starting the ablation, the capacitors were charged and pfa was applied as normal to the left veins.However, when moving to the lower right vein, two successful applications were applied, but on the third an error message appeared.The error message said "pfa generator fault" and "electrical short circuit in therapy pathway detected." the guidewire was checked and it was not touching any electrode, the balloon was repositioned and pulled slightly back, and the pfa was applied again, but the same error message appeared."hardware check failed" also appeared.The current generator was restarted, but when trying to open a case, it was not able to be opened.The generator was restarted several times, the case connected to the ensite x system and in standalone mode was opened, the generator was restarted with nothing connected, then the generator restarted with just the power supply connected, the power supply was plugged into different outlets, and the ensite x system was restarted, but the issue persisted.In total, the current generator was restarted around 15 times, but the issue was never resolved.The procedure was completed using an advisor hd catheter and tactiflex to isolate the right pv.There were no adverse consequences to 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 (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24507688
• Report Number: 2184149-2026-00055
• Device Sequence Number: 18632077
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11055640
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/28/2026

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: 11055640
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown