BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT MEDICAL SYSTEM, INC.

    MDR report key: 6913985 · Received October 4, 2017

    Report

    Report Number
    MW5072590
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 2, 2017
    Manufacturer
    MERIT MEDICAL SYSTEM, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN THE CATHETER WAS BEING REMOVED IT KINKED ON ITSELF WHICH MADE REMOVAL OF THE CATHETER DIFFICULT AND SUBSEQUENTLY CAUSED INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY WHICH REQUIRED STENTING TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694158 MERIT MEDICAL SYSTEM, INC. ANGIOGRAPH DQO MERIT MEDICAL SYSTEM, INC. 59038UAC E955797

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention