BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 8581889 · Received May 6, 2019

    Report

    Report Number
    8581889
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 9, 2019
    Report Date
    April 22, 2019
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ARTERIAL SEALING DEVICE DID NOT DEPLOY. THE BALLOON ON DEVICE INFLATED AND ADVANCED. THE TAMPER WAS NOT VISIBLE WHEN DEVICE ADVANCED AND CORDIS AVANTI SHEATH REMOVED. HEMOSTASIS NOT OBTAINED. THE ENTIRE SYSTEM WAS REMOVED AND LONGITUDINAL TEAR WAS OBSERVED AT END OF MINX SHEATH PREVENTING COLLAGEN AND TAMPER FROM EXITING SHEATH. PER HOSPITAL, THE REP INQUIRED ABOUT THE EVENT WITH QUESTIONS AND ANSWERS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376220 MYNXGRIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASI, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY MX6721 F1825602

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA