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

Model Number	PFA-GEN-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pulse field ablation (pfa) generator sn (b)(6) was received for evaluation.Analysis indicated that the pinnacle main controller unit (mcu) was supplying 5 v to the video cable, however the video splitter led was not illuminated.During troubleshooting, a smell of smoke was detected.The source was traced to the therapy control unit (tcu) board, where capacitor u55 was observed to be damaged.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.
Event or Problem Description
This report is to advise of thermal decomposition that was noted during analysis.During a pfa procedure, when connecting the two touchscreens and adding the boom monitor via an hdmi cable, it was noted that the screens remained black.Typically, after connecting the hdmi cable, the touchscreens would go black for a second before properly booting up.On the ensite x gui, it was seen that the current pfa generator was still connected but, despite multiple reboots with different cable configurations, no images were able to populate on the generator after the initial error.Since the generator screen would not turn on, the case was continued with a tactiflex catheter.The procedure was completed with 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; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25200556
• Report Number: 2184149-2026-00148
• Device Sequence Number: 10035768
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11115211
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/18/2026

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: 11115211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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