BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2830893 · Received November 13, 2012

    Report

    Report Number
    3004939290-2012-00412
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE FEMORAL HEAD VIA A 6F SHEATH (UNKNOWN MODEL). PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE RT WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE RT HAD DIFFICULTY SHUTTLING THE SEALANT DOWN THROUGH THE SHEATH AND WAS NOT ABLE TO RETRACT THE SHEATH. IT APPEARED THAT THE SEALANT "BEGAN TO SWELL INSIDE THE SHEATH AND IT LOOKED AS IF IT WAS CAUGHT ON THE ADVANCER TUBE, THE DEVICE WAS JAMMED." THEN THE DEPLOYER WAS ABLE TO RETRACT THE SHUTTLE BACK TO THE HANDLE BUT THE SEALANT CAME BACK WITH IT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION IN CONJUNCTION WITH A THROMBEX PATCH. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. THE PATIENT WAS DISCHARGED ON (B)(6) 2012.

    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 74 ANGIOMAX