BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840961 · Received November 20, 2012

    Report

    Report Number
    3004939290-2012-00434
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR A DEPLOYMENT JAM; HOWEVER, THE SEALANT WAS INSIDE THE SHUTTLE CARTRIDGE IN MANUFACTURING POSITION AND HAD NO EVIDENCE OF BLOOD. AN ATTEMPT TO INFLATE THE DEVICE REVEALED A LEAK AT THE BALLOON. VISUAL INSPECTION OF THE RETURNED DEVICE AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF LEAK WAS A LONGITUDINAL TEAR AT THE BALLOON, APPROXIMATELY 5MM FROM THE BALLOON PROXIMAL TIP. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE REPORTED DEVICE DEPLOYMENT JAM COULD NOT BE CONFIRMED. THE REVIEW OF THE LHR (LOT F1223302) 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 PATIENT UNDERWENT A DIAGNOSTIC NEURO PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 5F SHEATH (UNKNOWN MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE JAMMED. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 12 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITH NO CLINICAL SEQUELA THE SAME DAY ((B)(6) 2012).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 F1223302

    Patients

    Seq Age Sex Outcome Treatment
    1