BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840959 · Received November 20, 2012

    Report

    Report Number
    3004939290-2012-00427
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE ADVANCER TUBE WAS INSIDE THE SHUTTLE CARTRIDGE. THIS RECEIVED CONDITION INDICATES AN INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE. SHUTTLE DOWN PROCEDURE WAS SIMULATED AND THE ADVANCER TUBE WAS ABLE TO PROPERLY ENGAGE THE TAMP LOCKS. THE INTRODUCER SHEATH WAS INSPECTED FOR ANOMALIES (I.E. KINKS, DEFORMITY) THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING RETRACTION. NO ANOMALIES WERE OBSERVED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED EVENT COULD HAVE BEEN FROM INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE. THE REVIEW OF THE LHR (LOT F1223404) 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 (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY LEFT HEART CATHETERIZATION WITH GRAFTS PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE MID RIGHT COMMON FEMORAL ARTERY VIA A 6F SHEATH (UNKNOWN MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 6-7MM. 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. IT WAS REPORTED THAT THE BALLOON WAS INFLATED AND THE DEVICE WAS PULLED BACK TO THE ARTERIAL WALL (2ND STOP). THE SIDE PORT (STOPCOCK) ON THE SHEATH WAS OPENED THEN, THE PHYSICIAN SHUTTLED THE SEALANT DOWN THROUGH THE SHEATH UNTIL RESISTANCE WAS FELT. THE PHYSICIAN WITHDREW THE SHEATH TO THE BLACK HANDLE AND THE WHITE ADVANCER TUBE WAS NOT VISIBLE (JUST THE CATHETER WAS VISIBLE). AT THAT TIME, THE SALES PROFESSIONAL INFORMED THE PHYSICIAN THAT THE SEALANT HAD NOT DEPLOYED TO THE ARTERY. THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS CONVERTED TO APPROXIMATELY 13 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS MOVED TO RECOVERY AND IT WAS NOTED THAT THE PATIENT'S GROIN FELT SOFT & DRY. HEMOSTASIS WAS MAINTAINED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO 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 F1223404

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR