BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853090 · Received July 19, 2012

    Report

    Report Number
    3004939290-2012-00224
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 18, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 F1211704) 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) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE RIGHT GROIN, BELOW THE FEMORAL HEAD, AT THE BIFURCATION, VIA A 6F SHEATH (MODEL UNK). THE PATIENT'S HEMOGLOBIN WAS NOTED AS 8.8. PERI-PROCEDURE THE PATIENT WAS ANTICOAGULATED WITH ANGIOMAX. FOLLOWING THE PROCEDURE, THE TECH WHO IS A TRAINED USER, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED PER THE IFU. WHEN THE TECH WAS REMOVING THE SHEATH, HE "FELT SOMETHING DISTAL AND LATERAL." THE TECH PUT THE DRAPE AWAY AND SAW A HEMATOMA APPROXIMATELY 5CM IN SIZE. MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES, THEN A CLAMP WAS APPLIED AT THE ACCESS SITE (DURATION UNK). THE PATIENT WAS KEPT OVERNIGHT AS ORIGINALLY SCHEDULED (NOT MYNX RELATED). NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1211704

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ANGIOMAX