MAUDE Adverse Event Report: ABBOTT MEDICAL VOLT¿ PFA CATHETER; NO MATCH

Model Number	A-VOLT-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation procedure for atrial fibrillation using pulsed field ablation (pfa), two splines were noted to have fractured.At the end of the procedure, resistance was encountered while retracting the catheter balloon into the agilis sheath.Following removal of the volt catheter, inspection revealed that two splines were fractured on the distal portion of the catheter.The physician reported that there were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One volt pfa, sensor enabled catheter was received for evaluation.The device was returned due to a balloon leak, difficulty inserting/removing, and spline detachments.Splines 3 and 4 were fractured at the distal crown of the basket assembly, pieces of the splines can be observed within the distal crown, consistent with the reported spline issues.The balloon assembly was fully submerged underwater, and a vacuum was able to be held with a syringe, no fluid leak was noted.Additionally, while the balloon assembly was still submerged, it was filled with air, no evidence of air bubbles was noted.No evidence of a leak was detected.The volt catheter was inserted and removed from a stock 13f agilis with no anomalies and minimal resistance due to the fractured splines was felt.The eeprom read normally with no anomalies noted.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached spline remains unknown.

• 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: 24858073
• Report Number: 3005334138-2026-00197
• Device Sequence Number: 9036736
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11267902(17)260902
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 05/12/2026

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: 09/02/2026
• Device Model Number: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Device Lot Number: 11267902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2026
• 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 Sex: Unknown