MAUDE Adverse Event Report: Abbott Medical Volt¿ PFA Catheter; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

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	08/29/2026
Type of Reportable Event	Death
Event or Problem Description
After a pulsed field ablation atrial fibrillation procedure using a volt catheter, advisor hd grid x catheter, agilis 13f sheath, ensite x, and a non-abbott (boston scientific versacross) wire, the patient experienced a stroke.The patient was found unresponsive four days following the procedure.Patient was noted to be cyanotic, with cold extremities and right sided hemiparesis.The patient was outside of the tpa thrombectomy window and was transferred to a neurological icu.A head ct showed large left mca territory infarct, complete loss of grey/white definition, and a midline shift.Additionally, the patient was noted to have such pronounced brain swelling that most treatments were not pursued.Prior to the procedure, a tee was performed to rule out thrombus as the patient had missed 1-2 does of their pradaxa prescription.It was noted when the ice catheter was advanced that a baseline effusion was present.The transseptal puncture was then performed using a non-abbott (boston scientific versacross) wire and sheath.Following transseptal puncture, the non-abbott wire and sheath were replaced with an agilis 13f sheath.It was noted that the effusion was still at baseline.The advisor hd grid x catheter was then advanced, and an initial voltage map of the left atrium was performed.The advisor hd grid x catheter was then exchanged for a volt catheter and the procedure was performed.The ablation was done with the volt catheter inflated at 8cc and there were no issues noted throughout the ablation.The volt catheter was then exchanged for the advisor hd grid x catheter for post-mapping to confirm isolation.All catheters were removed and the effusion was noted to be stable at the end of the procedure.There were no performance issues noted with any abbott devices.The patient was discharged later the same day and resumed their pradaxa.The patient passed away six days post-procedure.Additional information was received which notes the patient had an elevated intrinsic risk for stroke which may have been exacerbated by missed doses of the patient's anticoagulation medication prior to the procedure.The patient had a chadsvasc score of 3.
Additional Manufacturer Narrative
The product's serial number could not be obtained, therefore partial udi information is provided (d4), but full udi information is not available.

• Brand Name: Volt¿ PFA Catheter
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• 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 ; +1(651)756-5400
• MDR Report Key: 50902672
• Report Number: 3008452825-2026-00518
• Device Sequence Number: 10706420
• Product Code: QZI
• UDI-Device Identifier: 05415067053022
• UDI-Public: (01)05415067053022(10)11439737(17)270531
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P250022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 11439737
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2026
• 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: Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 234 LB