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

Lot Number	CL15429
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that visible air/bubbles occurred.It was reported that a faradrive sheath was selected for a pulse field ablation (pfa) to treat an atrial fibrillation (af).The sheath was prepared as normal, and no air was noted during the aspiration step.The sheath was flushed and aspirated correctly, and the dilator was inserted correctly.During insertion in the groin, the wire and dilator were removed.Then, aspiration was performed and no air was noted.The catheter was inserted into the sheath valve, and the guidewire was advanced approximately 10 cm.The physician performed two aspirations from the sheath, and both showed air in the sheath side port.Sheath was replaced and procedure was completed without patient complications.Product return is not expected as it was contaminated.It was further informed that no air was seen in the patient.

• 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: 50689658
• Report Number: 2124215-2026-48093
• Device Sequence Number: 21236142
• Product Code: DRA
• UDI-Device Identifier: 00191506043131
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: CL15429
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/26/2026
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 112 LB