BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853055 · Received August 14, 2012

    Report

    Report Number
    3004939290-2012-00263
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    July 20, 2012
    Report Date
    July 20, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1217203) 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 PT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE FEMORAL HEAD, VIA A 7F SHEATH (UNK MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL TO BE APPROXIMATELY 7 MM IN SIZE. PERI-PROCEDURE THE PT WAS ANTI-COAGULATED WITH ANGIOMAX AND PLAVIX. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT POST DEPLOYMENT AN INFERIOR HEMATOMA DEVELOPED. THE HEMATOMA WAS MANAGED WITH 30 MINUTES OF MANUAL COMPRESSION. THE HEMATOMA WAS NOTED AS OVAL AND 4X8 CM. THE PT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY ((B)(6) 2012), WITH NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1217203

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other PLAVIX| ANGIOMAX