BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 5623561 · Received May 2, 2016

    Report

    Report Number
    5623561
    Event Type
    Malfunction
    Date Received
    May 2, 2016
    Date of Event
    April 6, 2016
    Report Date
    April 19, 2016
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO USE THE MYNX CLOSURE DEVICE THE BALLOONS ON TWO OF THE DEVICES BURST WHEN DEPLOYED. THE THIRD DEVICE WAS SUCCESSFUL. NO PATIENT INJURY. BOTH DEVICES HAVE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278553 MYNXGRIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY 6F/7F FF1604007

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR