BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 22178857 · Received June 10, 2025

    Report

    Report Number
    2124215-2025-38054
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506043131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PULMONARY VEIN ISOLATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION IN THE LEFT ATRIUM, FARADRIVE STEERABLE SHEATH CLEAR, WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT AIR CONTAMINATION WAS NOTED AT THE THREE-WAY STOPCOCK. FARAWAVE WAS INSIDE WHEN AIR CONTAMINATION WAS NOTED. THE AIR WAS CONSTANTLY BEING WITHDRAWN DURING ASPIRATION WHEN REMOVING THE FARAWAVE FROM THE FARADRIVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ORIGINAL DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED IN FACILITY. IT WAS FURTHER INFORMED: A LOT OF AIR WAS FOUND WHEN THE CATHETER WAS REMOVED FROM THE SHEATH. THE AIR NEVER DISAPPEARED EVEN AFTER MULTIPLE ASPIRATIONS. A PUMP WAS USED FOR THE IRRIGATION OF SHEATH. IRRIGATION WAS DONE AT 60 CC/H. THE GUIDEWIRE WAS RIGHT AT THE TIP OF THE CATHETER INSIDE THE SHEATH. NO OTHER ISSUE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619152 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL13716 00191506043131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown