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

Lot Number	0039254360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	08/14/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that death, cardiac arrest, ventricular fibrillation, ventricular tachycardia, hypotension and bradycardia occurred.A concomitant procedure (ablation/left atrial appendage closure (laac)) was being performed.A watchman trusteer access system (was), a 31mm watchman flx pro laa closure device and delivery system (wds), a farawave catheter and a versacross connect access solution for faradrive were selected for use.After the ablation portion of the procedure, the laac procedure was completed without any reported complications.Electrocardiogram (ekg) monitoring showed no st-segment elevation or evidence of any lethal arrhythmias.At the conclusion of the procedure, the physician was in the process of closing the groin access site, and protamine was administered to reverse the effects of heparin anticoagulation.The anesthesia physician observed a sudden decline in the patient's blood pressure along with bradycardia.Cardiopulmonary resuscitation (cpr) was initiated.A transesophageal echocardiogram (tee) was performed to evaluate for a potential pericardial effusion or cardiac tamponade as a cause of the hemodynamic instability.No pericardial effusion was identified on tee.Despite resuscitative efforts, the patient remained unstable and experienced recurrent episodes of ventricular tachycardia (vt) and ventricular fibrillation (vf).Multiple defibrillation attempts were performed; however, the patient continued to degenerate into vt and vf.Due to the persistent ventricular arrhythmias and ongoing hemodynamic compromise, extracorporeal membrane oxygenation (ecmo) support was initiated.Even after ecmo cannulation, the patient continued to require cpr and repeated defibrillation because of recurrent vt/vf episodes.Given the continued instability, the patient was transported from the procedure room for computed tomography angiography (cta) evaluation, with possible impella placement being considered following imaging.The physician suspected the heart rate, and pressure issues were related to an unexpected reaction to protamine.The patient was admitted to the cardiovascular intensive care unit.The patient was reported to have passed away the next day while in the intensive care unit (icu).Product return is not expected as it was disposed.It was further informed that an autopsy was performed and if the ablation procedure is related to the cause of death is not available per account.Additionally, no issues were encountered with the rf wire nor dilator during or after transseptal puncture.
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?
• 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: 50671284
• Report Number: 2124215-2026-47823
• Device Sequence Number: 9272781
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148(17)280503(10)39254360
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 0039254360
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 05/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male