MAUDE Adverse Event Report: ABBOTT MEDICAL VOLT¿ PFA CATHETER; No Match

Model Number	A-VOLT-01
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One volt pfa, sensor enabled catheter was received for evaluation.Spline insulation was noted to be torn and shaft electrode 2 was detached from the distal shaft.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the spline damage and detached electrode is consistent with attempting to remove the catheter with force when resistance was encountered through the associated sheath that was noted to have damage to the inner diameter.The volt instructions for use (ifu) cautions users not to apply excessive force when advancing or withdrawing the catheter if resistance is felt.
Event or Problem Description
During post-ablation mapping with the volt catheter following pfa applications, the physician observed a new opaque object on fluoroscopy that had not been present earlier in the procedure.The volt catheter was removed from the patient, and the opaque object remained visible on fluoroscopy.Inspection of the catheter revealed that a portion of insulation on one of the splines had been sheared, though still partially attached.A new sheath was introduced, and the physician aspirated the foreign object from the right inferior pulmonary vein.The retrieved material was identified as a detached ring electrode originating from the shaft of the volt catheter.

• Brand Name: VOLT¿ PFA CATHETER
• Common Device Name: No Match
• 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 ; 6517565400
• MDR Report Key: 25059512
• Report Number: 3005334138-2026-00231
• Device Sequence Number: 9353723
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11241473(17)260820
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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 Expiration Date: 08/20/2026
• Device Model Number: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Device Lot Number: 11241473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• 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: 04/02/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2026
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 70 KG