MAUDE Adverse Event Report: Abbott Medical Current¿ PFA Generator; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Model Number	PFA-GEN-01
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise on thermal damage found during analysis.During an af procedure using rf and pfa (tactiflex duo), it was noted that the following error message was displayed on the current generator; "hard drive issue".The tactiflex duo catheter was replaced but the issue persisted.The procedure was completed using the tacticath.There were no patient consequences.
Additional Manufacturer Narrative
One current pfa generator (sn: (b)(6)) was received for evaluation.The reported event was confirmed through a post failure that identified an internal load test failure.Based on the information provided to abbott and the investigation performed, the root cause of the post failure can be attributed to thermal damage to the pinnacle bfc pca.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: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• 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 ; +1(651)756-5400
• MDR Report Key: 50236650
• Report Number: 2184149-2026-00223
• Device Sequence Number: 10336336
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11023566
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P250022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 11023566
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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