BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2831611 · Received November 14, 2012

    Report

    Report Number
    3004939290-2012-00415
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF LEAK WAS A DIAGONAL TEAR AT THE BALLOON, APPROXIMATELY 5MM FROM THE BALLOON PROXIMAL TIP. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1221206) 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 COMMON FEMORAL ARTERY VIA A 6F SHEATH (UNKNOWN MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM BELOW THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 7MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING PULL BACK BEFORE THE ARTERIOTOMY WAS REACHED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 15 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME ON (B)(6) 2012 WITH NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1221206

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR