MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE?; See H11

Lot Number	0039312474
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a persistent atrial fibrillation ablation procedure, a farawave 2.0 catheter was selected for use and introduced through a non-boston scientific 13 fr sheath.During the initial insertion of the catheter, a suspected air embolism occurred, resulting in hypotension and inferior st-segment elevation observed on a 12-lead ecg while ablation was being performed at the left superior pulmonary vein.No malfunction of the farawave catheter was noted, and the catheter had not been removed and reinserted prior to the event.The patient was under general anesthesia without apneic episodes, high tidal volume, or any known condition that could have contributed to negative intrathoracic pressure.Interventions included increasing the fraction of inspired oxygen (fio2), administration of intravenous nitroglycerin, observation, and termination of the procedure.The st-segment elevation resolved completely prior to case completion; however, the cause of the st-segment elevation remains unknown.No imaging was performed, and no air was visualized within the patient.Additionally, no neurological or cardiac complications were reported.The patient remained neurologically intact, followed commands appropriately, was transferred to the post-anesthesia care unit for recovery, and was subsequently discharged without complications or complaints.No hospitalization or prolongation of hospitalization was required as a result of the event.The device is not expected to be returned for evaluation.
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: See H11
• 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: 50671610
• Report Number: 2124215-2026-47829
• Device Sequence Number: 13305527
• Product Code: QZI
• UDI-Device Identifier: 00191506043216
• UDI-Public: (01)00191506043216(17)270512(10)39312474
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/29/2026

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: 0039312474
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/12/2026
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 226 LB