BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853083 · Received August 8, 2012

    Report

    Report Number
    3004939290-2012-00254
    Event Type
    Injury
    Date Received
    August 8, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF THE LEAK WAS A LONGITUDINAL TEAR IN THE BALLOON, APPROXIMATELY 5 MM FROM THE BALLOON PROXIMAL TIP. NO OTHER SOURCE OF A LEAK WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1217201) 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 VASCULAR CLOSURE SPECIALIST THAT AN (B)(6) FEMALE PT UNDERWENT A DIAGNOSTICS CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE BIFURCATION, VIA A 6F SHEATH (UNK MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL APPROXIMATELY 7MM IN SIZE. FOLLOWING THE PROCEDURE, THE PHYSICIAN, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED PER THE IFU WITHOUT ANY ISSUES. THE DEVICE WAS INSERTED INTO THE PT AND THE BALLOON RUPTURED UPON PULLBACK, WHEN REACHING SECOND STOP. THE DEVICE WAS REMOVED FORM THE PT, AND THE PT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION. THERE WAS "NO HARM TO THE PT." REPORTEDLY, THE PT WAS HOSPITALIZED RELATED TO THE MYNX PROCEDURE, THE PT WAS DISCHARGED FORM THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012, THE ACI VASCULAR CLOSURE SPECIALIST REPORTED THAT THE PT WAS AN OUTPT AND THE PROCEDURE WAS DONE LATE IN THE DAY. SINCE THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F FAILED, THE DISCHARGE TIME WOULD HAVE BEEN AFTER MIDNIGHT. SO THE PT WAS KEPT OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1217201

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R