BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MGB

    MDR report key: 5089598 · Received September 18, 2015

    Report

    Report Number
    3004939290-2015-00448
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 11, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION PROVIDED THE POSSIBLE CAUSE OF PULSATILE BLOOD FLOW AROUND ADVANCER TUBE IS OVER-TAMPING BY THE USER. EXCESSIVE TAMPING MAY PLANT THE TIP OF ADVANCER TUBE DEEP INTO THE FREEZE-DRIED SEALANT RESULTING IN SEALANT ADHERED TO THE ADVANCER TUBE. THEN DURING THE REMOVAL OF THE ADVANCER TUBE THE SEALANT COULD BE DISLODGED FROM ABOVE THE ARTERIOTOMY THUS ALLOWING BLOOD TO FLOW AROUND THE SEALANT. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: NOTE: DI NUMBER AND PI NUMBER ARE UNKNOWN AS THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED BY THE COMPANY REPRESENTATIVE: THE PHYSICIAN DEPLOYED THE MYNXGRIP VASCULAR CLOSURE DEVICE FOLLOWING THE PROCEDURE. I WAS TOLD THERE WAS PULSATILE BLOOD FLOW AROUND THE ADVANCER TUBE DURING THE DEPLOYMENT. THE PHYSICIAN REMOVED THE MYNXGRIP VASCULAR CLOSURE DEVICE AND HELD PRESSURE FOR APPROXIMATELY 5 MINUTES AND THE SITE APPEARED FINE. A SHORT TIME LATER IN RECOVERY THE SITE BEGAN BLEEDING AGAIN AND ADDITIONAL MANUAL COMPRESSION FOLLOWED BY PLACEMENT OF A FEMOSTOP DEVICE WAS REQUIRED TO REGAIN HEMOSTASIS. NO ANTIBIOTICS WERE GIVEN. THE PATIENT WAS NOT HOSPITALIZED. PROCEDURE TYPE: DIAGNOSTIC CORONARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617575 MGB MGB CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention