BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853105 · Received July 12, 2012

    Report

    Report Number
    3004939290-2012-00192
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1214504) 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 "HEAVY", (B)(6) FEMALE PT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE MID FEMORAL ARTERY, VIA A 6F SHEATH (MODEL UNK). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE APPROX 5 MM. PERI-PROCEDURE, THE PT WAS ANTICOAGULATED WITH HEPARIN. THE PT'S ACT WAS NOTED AS 240. FOLLOWING THE PROCEDURE, THE TECH WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT A CRESCENT SHAPED HEMATOMA, 2 INCHES DISTAL FROM THE SITE. MANUAL COMPRESSION WAS HELD FOR 5 MINS, AND THE SITE SOFTENED, THEN IT BECAME HARD ABOVE THE ACCESS SITE AND PAINFUL. MANUAL COMPRESSION WAS HELD FOR 15 MINS, THE SITE SOFTENED, AND THE PT'S PAIN SUBSIDED. A HEMATOMA FORMED DOWN THE LEG, BELOW THE SITE. MANUAL COMPRESSION WAS HELD AGAIN, AND THE SKIN SOFTENED. AN ULTRASOUND WAS PERFORMED AND CONFIRMED A SMALL PSEUDOANEURYSM, WHICH WAS RESOLVED WITH 15 MINS OF MANUAL COMPRESSION. A FEMOSTOP WAS APPLIED. THE PT WAS REPORTED AS HOSPITALIZED (NOT MYNX RELATED), AND DISCHARGED FROM THE HOSPITAL THE NEXT DAY ((B)(6) 2012).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1214504

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention HEPARIN