BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 1936231 · Received December 9, 2010

    Report

    Report Number
    1936231
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ACCESS CLOSURE
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT LEFT HEART CATHETERIZATION. ACCESS WAS THROUGH THE RIGHT FEMORAL ARTERY. AT THE COMPLETION OF THE PROCEDURE AN ATTEMPT WAS MADE TO DEPLOY A MYNX CLOSURE DEVICE. THE DEVICE JAMMED AND COULD NOT BE DEPLOYED. MANUAL PRESSURE WAS HELD UNTIL HEMOSTASIS WAS OBTAINED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX DEVICE, VASCULAR, HEMOSTASIS MGB ACCESS CLOSURE MX6700 F1021005

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO OTHER THERAPIES