BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE (5F)

    MDR report key: 8037451 · Received November 5, 2018

    Report

    Report Number
    8037451
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 24, 2018
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DEVICE SEEMED TO GET STUCK ON THE PLUG, NOT ALLOWING ALL STEPS TO BE COMPLETED. THIS IS WHAT THE PATIENT SAFETY REPORT SAID: ROUTINE END OF CASE VASCULAR CLOSURE DEVICE DEPLOYMENT. AFTER INFLATION OF DEVICE BALLOON, DOCTOR ATTEMPTED TO PULL BACK SHEATH LEAVING VASCULAR CLOSURE PLUG AND BALLOON. WHEN ATTEMPTING TO REMOVE SHEATH THE INSIDE SUPPORTING STRAW/PLUG/BALLOON WERE REMOVED AS WELL, RATHER THAN BEING LEFT BEHIND AT ARTERIOTOMY SITE. MYNXGRIP COMPANY REPRESENTATIVE WAS CONTRACTED FOLLOWING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877284 MYNXGRIP VASCULAR CLOSURE DEVICE (5F) DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY MX5021 F1819101

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA