BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2855059 · Received December 3, 2012

    Report

    Report Number
    3004939290-2012-00450
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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. SEE MEDWATCH 3004939290-2012-00452 FOR THE SECOND DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON AN UNKNOWN DATE. ACCESS WAS OBTAINED VIA A 6F SHEATH (UNKNOWN MODEL). FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE "WHITE TAMP TUBE (ADVANCER TUBE) NEVER EXPOSED". THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED. A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F WAS DEPLOYED BUT THE "WHITE TAMP TUBE (ADVANCER TUBE)" ON THE SECOND DEVICE ALSO DID NOT EXPOSE. THE BALLOON ON THE SECOND DEVICE WAS ALSO DEFLATED AND THE DEVICE WAS REMOVED. AT THIS POINT THE PATIENT WAS CONVERTED TO APPROXIMATELY 10-15 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1