BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITREX GUIDEWIRE/N140801

    MDR report key: 1077185 · Received July 15, 2008

    Report

    Report Number
    MW5007649
    Event Type
    Injury
    Date Received
    July 15, 2008
    Date of Event
    April 22, 2008
    Report Date
    July 15, 2008
    Manufacturer
    EV3 PERIPHERAL VASCULAR DIVISION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 5 F DOUBLE LUMEN UMBILICAL VENOUS LINE PLACED OVER A MITREX/N140801 GUIDEWIRE. GUIDEWIRE APPEARED TO BE INTACT UPON REMOVAL. FILMS SHOWED RETAINED GUIDEWIRE TIP IN THE SUPERIOR VENA CAVA/RIGHT ATRIUM JUNCTION. RETAINED WIRE REMOVED. NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITREX GUIDEWIRE/N140801 GUIDEWIRE DQX EV3 PERIPHERAL VASCULAR DIVISION N140801 01991377

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability