MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARADRIVE Steerable Sheath Clear; Catheter, Steerable

Lot Number	CL15475
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ischemia Stroke (4418); Heart Block (4444)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fda medsun for medwatch notification: it was reported that that patient developed st elevations during pfa "[pulsed field ablation]" application of the rspv that was sustained and associated with hypotension and inferior wall motion abnormalities.Suspect air bubbles from pfa sheath as cause of st elevation.Post procedure, patient was found to have an air embolism in the brain causing ischemic injury (stroke).A faradrive sheath was selected for use to atrial fibrillation.It was noted that the patient had preexisting coronary heart disease.During the procedure, the torflex catheter was exchanged for the faradrive sheath and inserted the farawave catheter.The faradrive sheath was attached to continuous flush through a drip line that was carefully checked and prepped.The j-wire was positioned in each vein during the application.The patient developed transient st elevations that self-resolved within 2 minutes after the basket pulses were delivered in the lspv "[ left superior pulmonary vein]".No evidence of bubbles were seen in the cardiac chambers on ice imaging and there appeared to be no bubbles in the sheaths.The patients hemodynamics were stable and it elected to move forward with the remainder of the pulmonary veins.When 2 pulses were applied in the flower configuration, the patient once again developed st elevations in the inferior leads, but this time demonstrated hypotension with systolics as low as 66 mmhg and subsequent complete heart block.A coronary sinus catheter was inserted into the rv and applied ventricular pacing at 80 bpm.On tee "[transesophageal echocardiogram]", there were probable air bubbles in the lv with inferior wall motion abnormalities, and a coronary angiogram was performed.With injection of contrast into the rca, the patient's heart rate immediately increased to sinus tachycardia with immediate resolution of st segment elevation.There was no evidence of obvious bubbles in the rca territory.There was possibly sluggish flow in the acute marginal but was not intervened upon as the patient no longer exhibited wall motion abnormalities and showed recovery of her blood pressure and heart rhythm.They also injected the left coronary system which revealed no major abnormalities.Post procedure, the patient was found to have an air embolism in the brain causing ischemic injury (stroke).The patient was admitted for further hospitalization and required intervention to prevent permanent impairment/damage, however the intervention is unknown.

• Brand Name: FARADRIVE Steerable Sheath Clear
• Common Device Name: Catheter, Steerable
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50916734
• Report Number: 2124215-2026-51427
• Device Sequence Number: 5369807
• Product Code: DRA
• UDI-Device Identifier: 00191506043131
• UDI-Public: (01)00191506043131(17)280304(10)CL15475
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Lot Number: CL15475
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 03/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97610227-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female