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

Model Number	A-VOLT-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
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 cva could not be conclusively determined.
Event or Problem Description
One day following a pulsed field ablation (pfa) procedure, the patient reported abnormal vision.Subsequent magnetic resonance imaging (mri) confirmed a cerebrovascular accident (cva), with evidence of infarction in the subcortical white matter.The patient¿s hospitalization was extended; however, no therapeutic intervention was undertaken for the cva.Prior to the ablation procedure, intra-arterial thrombus was excluded via transesophageal echocardiography (tee).The reporting physician indicated that the etiology of the cva may be attributed either to the index procedure or to the patient¿s history of atrial fibrillation persisting for five days without anticoagulation therapy.Additionally, an arteriovenous (av) fistula was identified by duplex sonography.Management included repeated applications of manual compression and pressure bandaging over the subsequent days.The fistula was not associated with hemodynamic compromise at any point.A hematoma and localized pain were also observed.The physician assessed the av fistula as likely related to vascular access (puncture-related).No performance issues were identified with any abbott devices, and no unexpected procedural complications were reported.The patient had no prior history of cva.Anticoagulation during the procedure included heparin administration, with an average activated clotting time (act) of approximately 376 seconds.No anticoagulation bridging was performed.Relevant comorbidities included preexisting hypertension and obesity.

• 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: 25218828
• Report Number: 3008452825-2026-00280
• Device Sequence Number: 21280079
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11287187(17)270131
• 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): 05/19/2026

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 Model Number: A-VOLT-01
• Device Catalogue Number: A-VOLT-01
• Device Lot Number: 11287187
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male