BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 5832820 · Received July 29, 2016

    Report

    Report Number
    5832820
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    March 31, 2016
    Report Date
    June 3, 2016
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DEPLOY THE 6F MYNX IN THE RIGHT FEMORAL ARTERY, THE DOCTOR STATED THAT THE BALLOON BURST. MANUAL PRESSURE WAS HELD FOR 20 MINUTES TO OBTAIN HEMOSTASIS. MANUAL PRESSURE WAS HELD AND PATIENT WAS TRANSFERRED FROM THE CATH LAB WITH NO HEMATOMA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486264 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY 6F F1532901

    Patients

    Seq Age Sex Outcome Treatment
    1