BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3222676 · Received July 12, 2013

    Report

    Report Number
    3004939290-2013-00169
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 13, 2013
    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 WAS 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) MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. AN HOUR AND A HALF LATER, THE PATIENT WAS HYPOTENSIVE WITH BLOOD PRESSURE DROPPING TO THE 60'S (SYSTOLIC) AND COMPLAINING OF GROIN PAIN. WHEN THE PHYSICIAN ARRIVED THE PATIENT HAD A VERY LARGE HEMATOMA (GREATER THAN 6CM) WRAPPING AROUND THE INSIDE OF HIS THIGH. MANUAL COMPRESSION WAS APPLIED TO THE HEMATOMA FOR APPROXIMATELY 31 MINUTES AT WHICH TIME THE HEMATOMA WAS RESOLVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO CLINICAL SEQUELA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323575 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| O| R