MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE? NAV; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Lot Number	0039494471
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tachycardia (2095); Convulsion/Seizure (4406)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that seizure and atrial tachycardia occurred.It was reported that a farawave catheter and a faradrive sheath were selected for ablation to treat atrial fibrillation (afib).During procedure, farapulse pulmonary vein isolation (pvi) and pulmonary wall isolation (pwi) were performed.An atrial tachycardia (at) occurred, and chemical ablation was carried out.Non-boston scientific mapping and ablation catheters were inserted via faradrive to continue the ablation.Mitral isthmus ablation was performed.The procedure was completed.There was a delayed recovery from general anesthesia, and it was reported that generalized convulsions occurred.A head computed tomography (ct) scan was performed.The findings revealed a pre-existing old cerebral infarction, but none other than that.The patient was transferred to the intensive care unit (icu).As the sheath and other components remained in place, it was informed that the magnetic resonance imaging (mri) scan was planned to be performed at a later date.As this could be an epileptic seizure, the patient's condition was monitored.Product return is not expected as it was discarded in facility.
Additional Manufacturer Narrative
D2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.

• Brand Name: FARAWAVE? NAV
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50736517
• Report Number: 2124215-2026-48759
• Device Sequence Number: 10639259
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• UDI-Public: (01)00191506043193(17)270603(10)39494471
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Lot Number: 0039494471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 06/03/2026
• 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: Life Threatening; Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 147 LB