BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 3013865 · Received March 20, 2013

    Report

    Report Number
    3004939290-2013-00090
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE REVIEW OF THE LHR (LOT F1230301) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED BELOW THE IEA VIA A 5F BOSTON SHEATH. PERI-PROCEDURE THE PATIENT WAS ANTI-COAGULATED WITH 8,000 UNITS OF HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE >6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER THE DEVICE WAS DEPLOYED, LIGHT VENOUS PRESSURE WAS HELD FOR ABOUT 6-7 MINUTES. APPROXIMATELY 15 MINUTES AFTER THE DEVICE WAS DEPLOYED, WHILE THE PATIENT WAS ON THE TABLE IN THE PROCEDURE ROOM, A HEMATOMA (DESCRIBED AS LARGER THEN A GRAPEFRUIT IN SIZE) WAS NOTICED. IT WAS NOTED THAT THE PATIENT HAS A HERNIA, THEREFORE THE BLOOD (HEMATOMA) POOLED IN THE PATIENT'S SCROTUM. MANUAL PRESSURE WAS APPLIED AT THE ACCESS SITE FOR 2.5 HOURS IN CONJUNCTION WITH A SYVEK PATCH. WHILE THE PATIENT WAS IN RECOVERY, A TEN POUND SANDBAG WAS APPLIED AT THE ACCESS SITE. HEMOSTASIS WAS ACHIEVED AT THIS POINT. THE PATIENT DEVELOPED A HEMATOMA (GRAPE FRUIT SIZE) INTO HIS SCROTUM POST PROCEDURE. THE PHYSICIAN HAD PUNCTURED THE ARTERY THROUGH THE BACK WALL ON HIS FIRST ATTEMPT WHICH, HE STATED WAS THE CAUSE OF THE BLEED. THE PHYSICIAN SAID "THE MYNX DEVICE CLOSED THE SECOND STICK (ACCESS SITE) AND THAT THE PATIENT WAS PROBABLY BLEEDING THE ENTIRE PROCEDURE FROM THE BACK WALL STICK". THE PATIENT WAS HOSPITALIZED FOR UNRELATED AND UNSPECIFIED REASONS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116356 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 F1230301

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R 8,000 UNITS OF HEPARIN