BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2882323 · Received December 20, 2012

    Report

    Report Number
    3004939290-2012-00479
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 TAPER TO TAPER TEAR IN THE BALLOON, APPROXIMATELY 2.5MM FROM THE BALLOON PROXIMAL TIP. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1224204) 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 A (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE MID FEMORAL HEAD VIA A 6F TERUMO SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH ASPIRIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. THE DEVICE WAS PREPPED PER THE IFU. THE PHYSICIAN REPORTED THAT "HE NEVER FELT THE BALLOON ABUT TO THE SHEATH AND HE CONTINUED TO PULL BACK AND THE DEVICE CAME THRU THE SHEATH." THE BALLOON WAS TESTED OUTSIDE THE PATIENT'S BODY AND IT WAS FOUND THAT THE BALLOON WAS RUPTURED. HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH A SECOND MYNXGRIP DEVICE AND NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1224204

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR ASPIRIN