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 Codes	Failure to Deliver Energy (1211); High impedance (1291)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Perforation (2513)
Date of Event	09/09/2026
Type of Reportable Event	Death
Event or Problem Description
During a volt pvi procedure, a pericardial tamponade requiring sternotomy resulting in death was noted.Transseptal access was obtained using an agilis sheath and brk needle.The lspv was accessed with a non-abbott (merit) inqwire guidewire, with the volt catheter being advanced to the ostium of the lspv.The volt balloon was inflated with 10 cc of saline and contrast medium, and respiratory compensation for catheter movement was performed.The baseline calibration was conducted by rotating the balloon and moving it forward and backward.The first pfa application was initiated, reach 90% completion and the system automatically aborted the application with the error message stating "pfa generator fault - therapy pathway resistance exceeded the acceptable limit".The catheter was disconnected and reconnected, confirmed to be fully inflated and confirmed the guidewire was positioned within the pulmonary vein and not in contact with the splines.Baseline was repeated and the second application was delivered 100% with auto marks.Two subsequent applications were automatically aborted by the system.The generator was restarted, the pfa unified cabled and pfa gen connect cables were disconnected and reconnected.Baseline was performed again and applications 5 and 6 in the lspv were delivered successfully.The physician attempted to advance into the lipv approximately 2 minutes after application 6 and the patient developed emerging bradycardia which was paced via the cs catheter.The patient hemodynamic status continued to decline, and a pericardial tamponade was identified with fluoroscopy.A pericardial effusion was attempted and unsuccessful requiring a cardiac surgeon to perform a sternotomy to control the bleeding.The bleeding could not be controlled and the patient died on the procedure table.

• 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50818987
• Report Number: 3008452825-2026-00516
• Device Sequence Number: 16122455
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11464244(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/18/2026

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
• Device Lot Number: 11464244
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2026
• 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: Death
• Patient Sex: Unknown