BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 4397029 · Received November 10, 2014

    Report

    Report Number
    3004939290-2014-00189
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT TO INFLATE THE BALLOON FROM THE RETURNED DEVICE WITH WATER REVEALED A LEAK. VISUAL INSPECTION AT HIGH MAGNIFICATION CONFIRMED THA THE SOURCE OF THE LEAK WAS LONGITUDINAL TEAR ON THE BALLOON, APPROXIMATELY 5MM FRO THE BALLOON PROXIMAL TIP. THE REVIEW OF THE LHR (LOT F130504) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE TEAR COULD NOT BE DETERMINED. SEE MDR 3004939290-2014-00190 FOR THE SECOND DEVICE.

    Description of Event or Problem · 1

    THE ACI SALES PROFESSIONAL REPORTED THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED "MINIMAL" PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 9MM. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING PULL BACK. THE DEVICE WAS REMOVED AND SINCE ACCESS WAS MAINTAINED A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 6F7F WAS DEPLOYED. THE BALLOON FROM THE SECOND DEVICE ALSO RUPTURED. THE SECOND DEVICE WAS REMOVED AND A DEVICE FROM ANOTHER MANUFACTURER (ANGIOSEAL) WAS DEPLOYED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724472 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1305104

    Patients

    Seq Age Sex Outcome Treatment
    1 ANGIOMAX