BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILLIPS IVUS CATHETER

    MDR report key: 22340150 · Received June 25, 2025

    Report

    Report Number
    MW5171985
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 18, 2025
    Report Date
    June 18, 2025
    Manufacturer
    PHILLIPS 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

    IVUS CATHETER DID NOT CAPTURE IMAGES APPROPRIATELY. IVUS CATHETER REMOVED AND NEW ONE OPENED AND USED TO OBTAIN IMAGES DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003578 PHILLIPS IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILLIPS ULTRASOUND LLC 85900P 0303460823

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male