MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE? NAV; 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 Code	Ischemia Stroke (4418)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that during a pulmonary vein isolation (pvi) procedure for an atrial fibrillation treatment, a farawave catheter was selected.It is reported that patient had a watchman implant on (b)(6)2026.No abnormalities detected on 45-day transesophageal echocardiogram (tee).Patient received a ct scan on (b)(6) 2026 in preparation for a pvi.Findings from the ct scan was a possible clot on the watchman device.Patient was sent home on eliquis and pvi was postponed.Pvi was performed on (b)(6) 2026, no tee was performed prior to pvi.Patient reported challenges walking following pvi to anesthesia provider.Patient returned to hospital for neuro scan (unknown which modality) on (b)(6) 2026.Findings from scan was possible prior stroke.Patient was discharged from hospital on (b)(6) 2026.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because sales representative has not responded.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• Brand Name: FARAWAVE? NAV
• 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: 50813102
• Report Number: 2124215-2026-49872
• Device Sequence Number: 10152458
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/30/2026

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
• 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: 08/24/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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 Age: 75 YR
• Patient Sex: Female