BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX

    MDR report key: 17197501 · Received June 26, 2023

    Report

    Report Number
    17197501
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 20, 2023
    Manufacturer
    EV3, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF NITREX GUIDEWIRE SHEARED OFF AND WAS RETAINED EXTRAVASCULARLY WHILE ATTEMPTING LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH. IMMEDIATELY CONTACTED SURGEON, AND THEN PEDS SURGERY DOCTOR. DETERMINED IT WAS SAFE TO LEAVE IN PLACE. PROCEEDED AND COMPLETED CASE WITH NO OTHER ISSUES. DOCTOR NOTIFIED PATIENT FAMILY AT COMPLETION OF CASE. SPECIFIC ITEM: EV3 NITREX .018" X 80 CM GUIDEWIRE. REF# N180801, LOT# 6675783. USED IN CONJUNCTION WITH ARGON MEDICAL DEVICES AMC/3 ARTERIAL NEEDLE 21GA X 1" REF# 195311.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931059 NITREX WIRE, GUIDE, CATHETER DQX EV3, INC. N180801 6675783

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Female