BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3112974 · Received May 15, 2013

    Report

    Report Number
    3004939290-2013-00126
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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

    THE ACI SALES PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE 6MM. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT HEMOSTASIS WAS OBSERVED POST DEPLOYMENT. WHEN THE PATIENT WAS IN THE ICU FLOOR (INTENSIVE CARE UNIT) THE PATIENT DEVELOPED A RETROPERITONEAL BLEED (RP BLEED). THE LAB MONITORED THE PATIENT FOR CHANGE IN BLOOD LEVELS AND NOTED THAT THE LEVELS DECREASED BY 4 GRAMS. A CAT SCAN WAS PERFORMED WHICH REVEALED THAT THE HEMORRHAGE (RETROPERITONEAL BLEED) EXTENDED FROM THE RIGHT LOBE OF THE PATIENT'S LIVER TO THE PELVIS. PRESSURE WAS HELD FOR AN UNKNOWN AMOUNT OF TIME. THE PATIENT WAS REPORTED AS "STABLE". THE PATIENT'S DISCHARGED DATE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215486 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R HEPARIN