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 Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of thermal damage found during investigation.During a procedure with tactiflex duo catheter, the catheter was successfully connected to the current generator and placed in the heart.The energy was charged to 100%.Before the first ablation, a loud sound was heard from the generator and an error message appeared which had a restart button.The exact message was not clear but it mentioned "low voltage detected".The generator was restarted two times with no resolution and another error appeared saying "hardware issue detected".The generator was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One current pfa generator was received for evaluation.Based on the information provided to abbott and the investigation performed, the root cause can be attributed to thermal damage to the pinnacle bridge pca and 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: 50344456
• Report Number: 2184149-2026-00224
• Device Sequence Number: 12191101
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)10944254
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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): 08/20/2026

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: 10944254
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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