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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969)
Date of Event	08/31/2026
Type of Reportable Event	Death
Event or Problem Description
During a posterior wall isolation and pulmonary vein isolation procedure for the treatment of an atrial fibrillation, a farawave catheter was selected.During procedure, the physician went transeptal with a brk needle and mapped with a non-boston scientific catheter through a non-boston scientific sheath.Then exchanged for a faradrive and used a non- nav farawave 35 mm to ablate.Catheter details are unknown but there were no issues with deployment or the catheter itself.The ablation proceeded normally and the physician found no effusion at the end.There were no notable changes in vital signs during the case.Standard aspirations and flushes were done.This physician has asked for no guidance, and field specialist was just watching his aspirations and flushes to monitor the sheath.The case concluded and the lab manager reached out around 4 hours later to inform that the patient has coded several times and may not survive.Afterward, it was reported that the patient died after experiencing a myocardial infarction following the procedure.

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50899581
• Report Number: 2124215-2026-51243
• Device Sequence Number: 5829620
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• 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: 09/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown