BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 2527419 · Received April 6, 2012

    Report

    Report Number
    3001627457-2012-00004
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 8, 2012
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL # 50CM. INVESTIGATION SUMMARY: INSPECTION OF THE RETURNED CATHETER CONFIRMED THE MARKER BANDS HAD BEEN PROPERLY SWAGED ONTO THE CATHETER DURING MANUFACTURE. THE PINCH MARKS LEFT BY THE SWAGED BANDS WERE CLEARLY VISIBLE. THE USER REPORTED USING THE DEVICE WITH AN INTRODUCER SHEATH THAT HAD A TOUGHY-BORST TYPE ROTATING HEMOSTASIS VALVE. THE CONDITION OF THE DEVICE WAS CONSISTENT WITH HAVING BEEN WITHDRAWN THROUGH THE ROTATING HEMOSTASIS VALVE BEFORE IT HAD BEEN ADEQUATELY LOOSENED RESULTING IN REMOVAL OF THE MARKER BANDS.

    Description of Event or Problem · 1

    AFTER A SUCCESSFUL PROCEDURE, AS THE DEVICE WAS BEING REMOVED FROM THE PT, BOTH MARKER BANDS WERE STRIPPED OFF INSIDE THE INTRODUCER SHEATH. BOTH MARKER BANDS WERE RETRIEVED USING A SMALL BALLOON CATHETER. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 135CM 110815018-002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK