BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 24735330 · Received March 30, 2026

    Report

    Report Number
    2124215-2026-17363
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 23, 2026
    Report Date
    March 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506042516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FARADRIVE SHEATH WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITH FARAVIEW TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION. THE SHEATH WAS PREPARED, AND IRRIGATION WAS PERFORMED WITH A PRESSURE BAG. WHEN A FARAWAVE CATHETER WAS INSERTED INTO THE FARADRIVE SHEATH, THE SHEATH VALVE WAS REPORTEDLY NOT COMPLETELY LEAK TIGHT, RESULTING IN AIR BUBBLES TO KEEP FORMING IN THE SYRINGE DURING PURGING. PRIOR TO THIS, ONLY THE DILATOR, 71CM NRF TRANSSEPTAL NEEDLE, AND GUIDEWIRE WERE INSERTED INTO THE SHEATH. THE GUIDEWIRE WAS RETRACED IN THE FARAWAVE WHEN IT WAS INSERTED INTO THE SHEATH. THE PHYSICIAN CHANGED THE SHEATH TO CONTINUE THE PROCEDURE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. NO AIR WAS SEEN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798812 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL14854 00191506042516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown