BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE GUIDE WIRE

    MDR report key: 23604889 · Received November 20, 2025

    Report

    Report Number
    MW5179129
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 17, 2025
    Report Date
    November 18, 2025
    Manufacturer
    VOLCANO CORPORATION / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF PHILIPS OMNIWIRE PRESSURE GUIDE WIRE LEFT BEHIND IN PATIENT'S NATIVE VESSEL. STENTING REQUIRED IN ORDER TO PREVENT FURTHER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076036 PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV 0303574827

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other