BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840955 · Received November 20, 2012

    Report

    Report Number
    3004939290-2012-00431
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, THE ROOT CAUSE OF THE REPORTED EVENT 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 CLINICAL SPECIALIST THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED ABOVE THE BIFURCATION 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. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT HEMOSTASIS WAS ACHIEVED INITIALLY AFTER THE DEVICE WAS DEPLOYED AND 3 MINUTES OF PRESSURE WAS APPLIED. AFTER THE PATIENT WAS MOVED TO THE BED THE ACCESS SITE WAS CHECKED AND A HEMATOMA (SIZE UNKNOWN) WAS STARTING TO FORM. MANUAL COMPRESSION WAS APPLIED AND THE HEMATOMA CONTINUED TO GROW WHILE THE TECHNICIAN WAS HOLDING PRESSURE. MANUAL PRESSURE WAS APPLIED FOR AN HOUR AND A HALF AND THE HEMATOMA WOULD NOT STOP GROWING. EVENTUALLY THE HEMATOMA WRAPPED AROUND THE BACK OF THE PATIENT'S LEG AND INTO HER ABDOMINAL AND GROIN AREA. THE VASCULAR SURGEON WAS CONSULTED AND HE RECOMMENDED TO KEEP A WATCH ON THE HEMATOMA FOR THE REST OF THE DAY. WHEN THE HEMATOMA FINALLY STOPPED GROWING A PRESSURE BANDAGE WAS APPLIED AND THE PATIENT WAS SENT TO A ROOM. THE PATIENT WAS REPORTED AS HOSPITALIZED DUE TO THE MYNX PROCEDURE.

    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 67 YR Hospitalization| L| O| R ANGIOMAX