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

Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Vasospasm (2128); Syncope/Fainting (4411)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2a: common device name is percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation.
Event or Problem Description
A hypotension is reported during a pulmonary vein isolation for an atrial fibrillation procedure, a farawave catheter and a versacross connect were selected.During procedure, a patient received a pulsed field ablation with the farawave catheter on the cavotricuspid isthmus (cti).2mg of nitro was given as an infusion and then the cti was ablated with 9 applications with no issues.Transseptal was performed, left atrium was mapped and farawave was inserted into the left atrium and left superior pulmonary vein.1 application was delivered in basket, and the patient had an approximately 15-20s cardiac pause is classified as an arrhythmia followed by profound hypotension.Hypotension was treated with epinephrine and eventually resolved.Procedure was incomplete, canceled, or rescheduled.After procedure as patient was being woken up, there appeared to be changes to st segments confirming a st elevation.Patient was sent to cath (cardiac catheterization) lab for a cath procedure to determine status of coronaries.Cath did not show noticeable coronary vasospasm.

• 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: 50269216
• Report Number: 2124215-2026-43895
• Device Sequence Number: 13402957
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 09/18/2026

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: 07/22/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown