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

Model Number	A-VOLT-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pfa/af procedure, heart block occurred after a vagal response following the first pfa application.Prior to the first pfa application in the lspv, atropine was not administered.After the first application, the patient had a vagal response that progressed to complete heart block.The pfa application was stopped due to an inability to r-wave gate.Pacing was attempted with the cs catheter without capture.The cs catheter was then repositioned to the rv and pacing was successfully achieved.After about 2 minutes of rv pacing, the patient's intrinsic rhythm returned.A quadripolar catheter was placed in the rv for backup pacing and atropine was administered.During the second pfa application in the lspv, the patient developed complete heart block again.Rv pacing was initiated, and pfa application was completed.Complete heart block also occurred during the third lspv application and again during the first pfa application in the lipv, requiring pacing each time.The procedure was completed.The patient remains stable.No other intervention was needed after.The physician alleges that the volt pfa applications were the cause of the heart block.There were no performance issues with any abbott device.

• Brand Name: Volt¿ PFA Catheter
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50455400
• Report Number: 3005334138-2026-00438
• Device Sequence Number: 10281691
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: 05415067053022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P250022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Was Device Available for Evaluation?: No
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown