BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORPORATION GUIDEWIRE V-18

    MDR report key: 18978368 · Received March 25, 2024

    Report

    Report Number
    MW5153140
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 15, 2024
    Report Date
    March 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDEWIRE V-19 SHORT TAPER WITH ICE HYDROPHILIC COATING CONTROL WIRE UTILIZED IN INTERVENTIONAL CATH PROCEDURE WAS NOTED TO BE FRAYED. IMAGING SHOWED A THREAD LIKE PIECE SHEARED OFF AND WAS LEFT IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047593 BOSTON SCIENTIFIC CORPORATION GUIDEWIRE V-18 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001468600

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female