MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE? NAV; See H11

Lot Number	0039425206
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Intracranial Hemorrhage (1891)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced cerebral hemorrhage and aortic aneurysm.A farawave catheter was selected for use during a pulsed field ablation (pfa) procedure.The procedure was completed with the device with not apparent issues; a non-boston scientific sheath was used.The patient was discharged the day after the ablation procedure but then was readmitted several days later, at which time cerebral hemorrhage was confirmed.The reason for readmission was an aortic aneurysm in the groin.During readmission for an aortic aneurysm in the inguinal region, the patient's condition deteriorated, and a magnetic resonance imaging (mri) subsequently revealed a cerebral hemorrhage.The hospitalization period was estimated to be just under one week.Initially, it was suggested that the ablation may have caused a cerebral infarction, resulting in a cerebral haemorrhage.Subsequently, it was reported that the physician did not consider the cerebral haemorrhage to be causally related to the farapulse procedure.It was confirmed that no cerebral infarction occurred.No other catheter was inserted into the heart at the time of the patient injury, and no resistance was felt during device operation or removal.The event was reportedly attributed to medication.The details of the treatment are unknown; however, the patient was reportedly discharged from the hospital without further issues.
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: See H11
• 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: 50846961
• Report Number: 2124215-2026-50281
• Device Sequence Number: 15933541
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• UDI-Public: (01)00191506043193(17)270526(10)39425206
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 0039425206
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 05/26/2026
• 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 Sex: Unknown