BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3112969 · Received May 15, 2013

    Report

    Report Number
    3004939290-2013-00124
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1300305) 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 AN (B)(6) MALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE MID COMMON FEMORAL ARTERY VIA A 7F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 7MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER THE DEVICE WAS DEPLOYED AND A 5 MINUTE HOLD, THERE WAS "SOME" OOZING AT THE ACCESS SITE. MANUAL COMPRESSION WAS APPLIED FOR 10 MINUTES, AT WHICH TIME THE OOZING STOPPED BUT, A HEMATOMA APPROXIMATELY 4CM X 4CM DEVELOPED AT THE ACCESS SITE. AN ADDITIONAL 10 MINUTES OF MANUAL COMPRESSION WAS APPLIED WHICH APPEARED TO RESOLVE THE HEMATOMA. THEN, THE PATIENT WAS TAKEN TO RECOVERY, WHERE THE HEMATOMA RE-DEVELOPED. MANUAL COMPRESSION WAS APPLIED AGAIN FOR APPROXIMATELY 20 MINUTES FOLLOWED BY THE APPLICATION OF A FEMOSTOP (DURATION UNKNOWN) AFTER WHICH TIME, HEMOSTASIS WAS ACHIEVED. IT WAS NOTED THAT THE HEMATOMA DID NOT GET BIGGER THAN 4CM X 4CM IN SIZE BUT, THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT AS A PRECAUTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214407 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1300305

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R HEPARIN