BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 4258176 · Received November 14, 2014

    Report

    Report Number
    3004939290-2014-00674
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    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

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE CARTRIDGE WAS ENGAGED TO THE HANDLE. THE PROCEDURAL SHEATH WAS PULLED BACK AGAINST THE DISTAL END OF THE SHUTTLE. THE SEALANT AND THE ADVANCER TUBE WERE NOT RETURNED. THE CATHETER, SHUTTLE CARTRIDGE AND INTRODUCER SHEATH WERE INSPECTED FOR ANOMALIES THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING DEPLOYMENT. NO ANOMALIES WERE OBSERVED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE TO ACHIEVE HEMOSTASIS COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED JUST ABOVE BIFURCATION ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PROCEDURE, THE PHYSICIAN WHO SI A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED. IT WAS REPORTED THAT THE DEVICE FAILED DURING THE 90 SECOND SWELL PERIOD. APPROXIMATELY 60 SECONDS INTO THE 90 SECOND SWELL PERIOD, THERE WAS "STRONG" BLOOD/OOZING COMING OUT FORM THE ACCESS SITE. THE DEVICE WAS REMOVED. THE PATIENT WAS IMMEDIATELY CONVERTED TO MANUAL COMPRESSION ADN THE PATIENT WAS GIVEN PROTAMINE. MANUAL COMPRESSION WAS HELD FOR 20 MINUTES AND HEMOSTASIS WAS ACHIEVED WITH NO HEMATOMA OR BRUISING. TI WAS ALSO NOTED THAT THE PATIENT WAS DIFFICULT TO ACCESS AT THE BEGINNING OF THE PROCEDURE WITH A 5F SHEATH. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735623 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MS6721

    Patients

    Seq Age Sex Outcome Treatment
    1