BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALRUS BALLOON GUIDE CATHETER (BGC)

    MDR report key: 19269223 · Received May 7, 2024

    Report

    Report Number
    MW5154649
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 5, 2024
    Manufacturer
    Q'APEL MEDICAL, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CERVICAL LEFT INTERNAL CAROTID ARTERY DISSECTION AT SITE OF WALRUS BALLOON GUIDE CATHETER INFLATION WITH CONTRAST POOLING IN FALSE LUMEN, CREATING FUSIFORM DILATION AND REQUIRING ANTIPLATELET USE (ASPIRIN) TO PREVENT THROMBOEMBOLISM. THIS OCCURRED AFTER MECHANICAL THROMBECTOMY FOR INTRACRANIAL LARGE-VESSEL OCCLUSION (LEFT MIDDLE CEREBRAL ARTERY OCCLUSION). 95-CM 8F WALRUS BGC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477994 WALRUS BALLOON GUIDE CATHETER (BGC) CATHETER, PERCUTANEOUS DQY Q'APEL MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other