BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 6452881 · Received March 30, 2017

    Report

    Report Number
    MW5068841
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    January 16, 2017
    Report Date
    March 30, 2017
    Manufacturer
    ACCESSCLOSURE INC. A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A DIAGNOSTIC CAROTID ANGIOGRAM, WHICH SHOWED A 99 PERCENT RIGHT INTERNAL CAROTID STENOSIS. PT RECEIVED A MYNX CLOSURE DEVICE, WHICH FAILED AND REQUIRED MANUAL PRESSURE TO BE HELD TO CONTROL BLEEDING. (MYNX DEVICE WAS USED TO CLOSE THE RIGHT COMMON FEMORAL ARTERY PUNCTURE SITE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230646 MYNXGRIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE INC. A CARDINAL HEALTH COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization