BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVUS

    MDR report key: 22667160 · Received July 30, 2025

    Report

    Report Number
    MW5173542
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 24, 2025
    Report Date
    July 24, 2025
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNABLE TO ADVANCE IVUS CATHETER THROUGH 5 FRENCH SHEATH OVER COMMAND ES (EXTRA STIFF) WIRE WITHOUT RESISTANCE. SECOND IVUS DROPPED AND ABLE TO CROSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567925 IVUS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS ULTRASOUND LLC 0303265573

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female