BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 3212121 · Received July 8, 2013

    Report

    Report Number
    3004939290-2013-00165
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. THE SEALANT AND ADVANCER TUBE WERE NOT RETURNED. THE DEVICE WAS INSPECTED FOR ANOMALIES. NO ANOMALIES WERE FOUND. BASED ON THE INFORMATION PROVIDED, THE CONDITION OF THE RETURNED DEVICE, AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1306509) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VASCULAR CLOSURE SPECIALIST THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE LEFT GROIN VIA A 7F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED A MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED PER THE IFU. WHEN THE PHYSICIAN WAS DEFLATING THE BALLOON AND REMOVING THE ADVANCER TUBE FROM THE TISSUE TRACT THERE WAS SEALANT THAT APPEARED TO BE STUCK TO THE ADVANCER TUBE. THIS RESULTED IN WHAT APPEARED TO BE PULSATILE FLOW COMING FROM THE ACCESS SITE. THE PATIENT WAS CONVERTED TO 45 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO CLINICAL SEQUELA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310250 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB MGB ACCESSCLOSURE, INC. MX6701 F1306509

    Patients

    Seq Age Sex Outcome Treatment
    1 61 Required Intervention HEPARIN