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

Model Number	A-VOLT-01
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the pulsed field ablation procedure, an effusion was noted.The volt catheter did not display as expected on ensite.The balloon appeared off axis for most of the procedure.It also displayed anterior to the initial advisor hd grid x geometry.The display issue was most obvious at the lipv where the catheter also displayed as underinflated.On ice, it was confirmed that the catheter was fully inflated and the balloon was fully intact when checked after the procedure.This issue did not impede the ability to complete the procedure.There were also wide swings in the respiratory and the patient had a large effusion at baseline.At the end of the procedure, the sheath filter and respiratory compensation were turned off with no resolution.Baseline was performed again with no resolution either.The volt catheter was not replaced.
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 an effusion could not be conclusively determined.

• 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: 24837688
• Report Number: 3005334138-2026-00194
• Device Sequence Number: 21408931
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11241260(17)260816
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/09/2026

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 Expiration Date: 08/16/2026
• Device Model Number: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Device Lot Number: 11241260
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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