BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 11731437 · Received April 21, 2021

    Report

    Report Number
    11731437
    Event Type
    Injury
    Date Received
    April 21, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT DIAGNOSED WITH CALCIFIED 100% OSTIAL LESION IN LT SUBCLAVIAN AND TUBULAR 50% OSTIAL LESION IN RT SUBCLAVIAN. PATIENT UNDERWENT A PERIPHERAL ANGIOGRAPHY LEFT SUBCLAVIAN ANGIOGRAMS. UNABLE TO CROSS LEFT SUBCLAVIAN OCCLUSION BOTH RETROGRADE AND ANTEGRADE ENDED UP IN A SUBINTIMAL PLANE WITH NO RISK OF EMBOLIZATION. DISCLOSURE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596543 BOSTON SCIENTIFIC JUDO 3 STRAIGHT TIP GUIDEWIRE DQX BOSTON SCIENTIFIC JUDO 3 2436453

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| O