BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 5623541 · Received May 2, 2016

    Report

    Report Number
    5623541
    Event Type
    Malfunction
    Date Received
    May 2, 2016
    Date of Event
    October 12, 2015
    Report Date
    April 28, 2016
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DEPLOYING MYNX CLOSURE DEVICE, THE BALLOON RUPTURED. THE SHEATH WAS NOT OUT OF THE ARTERY; THE SHEATH WAS RE-INSERTED. AT THE END OF THE PROCEDURE THE ITEM WAS REMOVED IN AN UNDEPLOYED STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278870 MYNXGRIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1524601

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR