BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2853472 · Received November 30, 2012

    Report

    Report Number
    3004939290-2012-00446
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE RIGHT BIFURCATION VIA A 5F SHEATH (UNKNOWN MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE DURING PULL BACK TOWARDS THE ARTERIOTOMY. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1