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

Lot Number	0035929060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced atrial fibrillation.After a pulse field ablation (pfa) procedure to treat atrial fibrillation where a farawave 31 was selected for use a worsening of the atrial fibrillation occurred.Pfa and rf ablation (repeat ablation) were performed (targeting the pulmonary veins right superior pulmonary vein (rspv), right inferior pulmonary vein (ripv) and cavotricuspid isthmus (cti)) to resolve the issue.Both pulmonary vein isolation (pvi) and cti ablation were performed using a farawave catheter and an rf catheter.However, the customer/account was unable to specify which device was used for the cti ablation.The patient's condition subsequently improved.This case is reported to be associated with worsening of the patients pre-existing condition of atrial fibrillation (af).No specific medication administered for the worsening atrial fibrillation event was reported.The worsening of pre-existing atrial fibrillation occurred on (b)(6) 2025 after the first pfa procedure performed on (b)(6) 2025.The atrial fibrillation event did not result in hospitalization or prolonged hospitalization.Procedure was completed using the same device.It was indicated that the event was resolved.Patient current health status is unavailable per customer/account.

• Brand Name: FARAWAVE?
• 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: 50601438
• Report Number: 2124215-2026-47020
• Device Sequence Number: 10600230
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• 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,Followup
• Report Date (Section B): 09/30/2026

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: 0035929060
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 149 LB