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

Model Number	A-VOLT-01
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulsed field ablation procedure, there was a procedural delay.The volt catheter could not be advanced through the sheath.The catheter was fully deflated prior to attempting removal.No issues were noted during the deflation process.The lpv and rspv were isolated, and for the ripv the volt catheter was retracted into the agilis sheath, the sheath was rotated toward the ripv, and the guidewire was advanced to position in the ripv.However, the volt catheter would not advance out of the sheath.The volt catheter and agilis sheath were replaced and the procedure was completed with no adverse consequences to the patient.

• Brand Name: VOLT¿ PFA CATHETER
• Common Device Name: No Match
• 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 ; 6517565400
• MDR Report Key: 24841737
• Report Number: 3008452825-2026-00175
• Device Sequence Number: 15731177
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11219945(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Device Lot Number: 11219945
• 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: 03/14/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS¿ NXT STEERABLE INTRODUCER 13F.
• Patient Sex: Unknown