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

Model Number	A-VOLT-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident of a magnetic sensor issue could not be conclusively determined.
Event or Problem Description
During the pulsed field ablation pulmonary vein isolation procedure, there was a procedural delay due to a magnetic sensor issue.The catheter was recognized by the ensite x system, but an error appeared saying "catheter in port 7 has a magnetic sensor issue.Check connections and consider replacing the catheter or its cable" and the catheter was not visualized.The catheter was reconnected, the dws, amplifier, and current generator were rebooted with no resolution.Everything was reconnected again and the same troubleshooting was performed again.A different port on the amplifier was attempted with no resolution.After 12-15reboots and reconnections of the ensite x dws, ensite x amplifier, and current pfa generator the catheter was finally recognized and the procedure was completed with no adverse consequences to the patient.There was no visible defects noted and no issues noted during preparation.

• 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: 25232318
• Report Number: 3005334138-2026-00259
• Device Sequence Number: 16041507
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11160043(17)260619
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 05/20/2026

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: 06/19/2026
• Device Model Number: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Device Lot Number: 11160043
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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