BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2882799 · Received December 20, 2012

    Report

    Report Number
    3004939290-2012-00485
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 F1229803) 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 FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH HEPARIN AND INTEGRILIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE APPROXIMATELY 5MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE "GREEN SHUTTLE KNOB WOULDN'T GO DOWN SMOOTHLY AND WHEN THE PHYSICIAN PULLED THE SHEATH UP THERE WAS NO ADVANCER TUBE PRESENT". THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED. THE PATIENT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN TESTED THE DEVICE ON THE TABLE ONCE IT HAD BEEN REMOVED FROM THE PATIENT AND HAD GREAT DIFFICULTY SHUTTLING DOWN THE GREEN SHUTTLE KNOB FOR THE ADVANCER TUBE TO COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1229803

    Patients

    Seq Age Sex Outcome Treatment
    1 INTEGRILIN| HEPARIN