BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE

    MDR report key: 9122506 · Received September 26, 2019

    Report

    Report Number
    9122506
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 13, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ACCESSCLOSURE, INC. (A CARDINAL HEALTH COMPANY)
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A BILATERAL ILIAC ARTERY STENT PLACEMENT. MD REPORTED THAT THE MYNX CLOSURE DEVICE WAS DEPLOYED TO THE RIGHT GROIN SITE AT THE END OF THE PROCEDURE. THE PATIENT IMMEDIATELY DEVELOPED A HEMATOMA. PRESSURE WAS REQUIRED FOR APPROXIMATELY 40 MINUTES IN AN EFFORT TO SECURE HEMOSTASIS. NO ISSUES REPORTED OPERATING THE MYNX CLOSURE DEVICE. DUE TO THE PRESSURE REQUIRED, THE PATIENT ENDED UP HAVING A VAGAL REACTION THAT REQUIRED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919847 MYNXGRIP VASCULAR CLOSURE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC. (A CARDINAL HEALTH COMPANY) MX6721 1905202

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Other