BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1121203 · Received August 14, 2008

    Report

    Report Number
    3004939290-2008-00067
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED MALFUNCTION IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER IFU.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT AN UNCOMPLICATED ENDOVASCULAR PROCEDURE IN 2008. AT THE END OF THE PROCEDURE, MYNX VASCULAR CLOSURE DEVICE WAS USED BY A TRAINED OPERATOR TO ACHIEVE FEMORAL ARTERY HEMOSTASIS. THE SEALANT WAS DELIVERED SUCCESSFULLY AND IMMEDIATE HEMOSTASIS WAS ACHIEVED. DURING DEVICE REMOVAL, THE OPERATOR FELT RESISTANCE, BUT WAS ABLE TO SUCCESSFULLY REMOVE IT FROM THE TISSUE TRACT. IT WAS THEN NOTED THAT THE BALLOON APPEARED TO HAVE REMAINED INSIDE THE ADVANCER TUBE FOLLOWING DEVICE WITHDRAWAL, AND WAS SEPARATED FROM THE CATHETER. THE PATIENT WAS DISCHARGED NORMALLY PER STANDARD HOSPITAL PROCEDURE WITH NO REPORT OF ANY ADVERSE EVENT AS OF THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX MGB ACCESSCLOSURE, INC. MX6700 F0816204

    Patients

    Seq Age Sex Outcome Treatment
    1