BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALRUS BALLOON GUIDE CATHETER

    MDR report key: 23582587 · Received November 18, 2025

    Report

    Report Number
    MW5178968
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 13, 2025
    Manufacturer
    Q'APEL MEDICAL, INC.
    Product Code
    QJP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING DEPLOYMENT OF A WALRUS CATHETER DURING A THROMBECTOMY, THE BALLOON TIP RUPTURED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363750 WALRUS BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP Q'APEL MEDICAL, INC. FG250709P-01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization