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

Lot Number	CL15769
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulse field ablation (pfa) procedure for the treatment of atrial fibrillation (af), a faradrive steerable sheath was selected for use.During withdrawal of the sheath from the left atrium, aspiration was performed as part of the removal process.At that time, a large quantity of air bubbles was observed mid-sheath while the sheath was being withdrawn from the body.All observed air bubbles were successfully aspirated, and the patient was assessed and monitored for signs and symptoms of air embolism and stroke.No air was observed in the patient, and the patient did not experience a stroke.The procedure was completed successfully using the device.No adverse patient effects or complications occurred, and the patient remained stable throughout and following the procedure.

• 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: 50888710
• Report Number: 2124215-2026-50965
• Device Sequence Number: 10708011
• Product Code: DRA
• UDI-Device Identifier: 00191506043131
• UDI-Public: (01)00191506043131(17)280424(10)CL15769
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: CL15769
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/24/2026
• 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
• Patient Sex: Unknown