BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT MEDICAL SYSTEMS INC.

    MDR report key: 5900658 · Received August 22, 2016

    Report

    Report Number
    MW5064295
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 19, 2016
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 2-3 INCH OF THE WIRE TIP, UTILIZED TO ACCESS THE MESENTERIC SYSTEM VIA LEFT FEMORAL ARTERY, BROKE OFF DURING THE PROCEDURE. PROCEDURAL TIME INCREASED BY 25 MINUTES WHILE WIRE WAS RETRIEVED BY SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547219 MERIT MEDICAL SYSTEMS INC. 5F MERIT MAK MINI ACCESS KIT DRE MERIT MEDICAL SYSTEMS INC. MAK505-E 1961031

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention