BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3183390 · Received June 21, 2013

    Report

    Report Number
    3004939290-2013-00146
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY CATHETER WAS DISCARDED BY THE USER FACILITY AND ONLY THE ADVANCER TUBE AND A SMALL PIECE OF SEALANT WERE RETURNED FOR INVESTIGATION. THE SEALANT WAS RECEIVED SEPARATED FROM THE ADVANCER TUBE AND SOAKED IN BLOOD. THE ADVANCER TUBE WAS VISUALLY INSPECTED AND WAS FOUND FREE OF DAMAGE. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE SEALANT BEING STUCK TO THE ADVANCER TUBE COULD HAVE BEEN FROM EXCESSIVE TAMPING BY THE USER. EXCESSIVE TAMPING MAY PLANT THE TIP OF THE ADVANCER TUBE DEEP INTO THE FREEZE-DRIED SEALANT RESULTING IN SEALANT ADHERING TO THE ADVANCER TUBE. THEN DURING THE REMOVAL OF THE ADVANCER TUBE THE SEALANT COULD FOLLOW THE ADVANCER TUBE OUT OF THE TISSUE TRACT. THE REVIEW OF THE LHR (LOT F1232502) 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 DISTRIBUTOR THAT A PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 7F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH 4,000 UNITS OF HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 5MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED A MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT UPON REMOVAL OF THE WHITE ADVANCER TUBE FROM THE TISSUE TRACT, SEALANT WAS SEEN STUCK TO THE END OF THE ADVANCER TUBE. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO 10 MINUTES OF MANUAL COMPRESSION FOLLOWED BY A FEMOSTOP DEVICE WHICH WAS USED AT 30MM HG PRESSURE FOR 1 HOUR AND 30 MINUTES. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS HOSPITALIZED OVERNIGHT AND DISCHARGED FROM THE HOSPITAL THE NEXT DAY. THE PATIENT'S HOSPITALIZATION WAS NOT MYNX DEVICE/MYNX PROCEDURE RELATED. ONLY THE ADVANCER TUBE WITH REMNANTS OF SEALANT WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283238 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1232502

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CEFAZELFIN IV| 4,000 UNITS OF HEPARIN