BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 6439014 · Received March 28, 2017

    Report

    Report Number
    6439014
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    December 20, 2016
    Report Date
    March 9, 2017
    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

    AS THE DR WAS DEPLOYING A 5F MYNX DEVICE (LOT F1612303) INTO THE PATIENT'S RIGHT FEMORAL ARTERY SITE, A PIECE OF THE SEALANT CAME OUT. IT APPEARS THAT THE REMAINDER OF THE SEALANT REMAINED IN THE ARTERIOTOMY SITE AND WAS DEPLOYED PROPERLY ¿ SINCE LIGHT PRESSURE WAS HELD AS USUAL AND NO OOZING OR HEMATOMA WAS NOTED. THERE WERE NO FURTHER ISSUES. THE GROIN HAD NO BLEEDING, SWELLING OR HEMATOMA. THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222657 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY 5F F1612303

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR