BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 3014341 · Received March 13, 2013

    Report

    Report Number
    3001627457-2013-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED DEVICE CONFIRMED THE MARKER BANDS WERE NO LONGER PRESENT. SWAGE MARKS WHERE THE MARKER BANDS WERE INSTALLED WERE IDENTIFIED ON THE TUBING. THE USER CONFIRMED THEY PLACED THE IDDC THROUGH AN INTRODUCER SHEATH WITH A ROTATING HEMOSTASIS VALVE. THE PACKAGE INSERT FOR THE EKOSONIC ENDOVASCULAR DEVICE WARNS AGAINST THE USE OF SUCH INTRODUCER SHEATHS AS INADEQUATE OPENING OF THE VALVE DURING REMOVAL CAN RESULT IN DISLODGEMENT OF THE MARKER BANDS.

    Description of Event or Problem · 1

    FOLLOWING USE OF THE EKOSONIC DEVICE, AS THE DEVICE WAS BEING REMOVED FROM THE PT, THE PLATINUM MARKER BANDS WERE DISLODGED AND REMAINED IN THE PT. THE DEVICE WAS PLACED THROUGH AND INTRODUCER SHEATH WITH A ROTATING HEMOSTASIS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106378 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 106CM / 12 CM 110519011-005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK