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

Model Number	PFA-GEN-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pulse field ablation (pfa) generator was received for evaluation.The device was disassembled and the bfc was removed and appeared to have resistor damage to t13, r14, r17, r18, r19, r21, r24 (surrounding r13 r19 is observable thermal radiation).Further investigation inspected the pinnacle relay interface, pinnacle focal relay, pinnacle relay slots 0-3, and the bridge boards slots 0-3.It was observed on bridge board slot 3 thermal electrical damage was found on and around locations oh1, ol1, c48, c49, c50, c51, r44, and r69 (additionally potentially rh1 and c33).The field reported event was able to be replicated by post sequencing and internal visual inspections.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to electrical damage to bridge board slot 3 and the therapy control unit.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 damage found on the device during analysis.During an atrial fibrillation procedure, when using the volt 2.0 catheter in the left atrium, it was noted that the current pfa generator had returned to default after an audible sound was heard.Since a study was unable to be ran on the current pfa generator after, the issue was resolved by changing to a different system to continue the case.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h11.One pulse field ablation (pfa) generator was received for evaluation.The bfc was removed and appeared to have resistor damage to t13, r14, r17, r18, r19, r21, r24 (surrounding r13 r19 is observable thermal radiation).Further investigation inspected the pinnacle relay interface, pinnacle focal relay, pinnacle relay slots 0-3, and the bridge boards slots 0-3.It was observed on bridge board slot 3 thermal electrical damage was found on and around locations oh1, ol1, c48, c49, c50, c51, r44, and r69 (additionally potentially rh1 and c33).The field reported event was able to be replicated by post sequencing and internal visual inspections.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to electrical damage to bridge board slot 3 and the bfc.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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25132842
• Report Number: 2184149-2026-00141
• Device Sequence Number: 15618609
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11104642
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/09/2026

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: 11104642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• 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
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/09/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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