BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2873176 · Received December 13, 2012

    Report

    Report Number
    3004939290-2012-00476
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1229706) 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 VASCULAR CLOSURE SPECIALIST THAT A FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE LEFT COMMON FEMORAL ARTERY VIA A 6F SHEATH (UNKNOWN MODEL). PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED 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 APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE RN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE HELD PRESSURE DURING PREP AND THE INFLATION INDICATOR DID POP UP. THE DEVICE WAS INSERTED INTO THE PATIENT AND THE BALLOON LOST PRESSURE DURING PULLBACK BETWEEN FIRST AND SECOND STOP. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION IN CONJUNCTION WITH A QUICK CLOT PATCH. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO REPORTED 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 F1229706

    Patients

    Seq Age Sex Outcome Treatment
    1 4,000 UNITS HEPARIN