BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 2527399 · Received April 6, 2012

    Report

    Report Number
    3001627457-2012-00005
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL # 30CM. 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 THE CONDITION OF THE DEVICE WAS CONSISTENT WITH HAVING BEEN WITHDRAWN THROUGH A ROTATING HEMOSTASIS VALVE BEFORE IT HAD BEEN ADEQUATELY LOOSENED RESULTING IN REMOVAL OF THE MARKER BANDS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE INFUSION PUMP ALARMED AND COULD NOT BE RESTARTED. THE EKOSONIC DEVICE WAS RETURNED FOR EVAL. DURING EXAMINATION OF THE DEVICE, IT WAS DISCOVERED THAT THE DISTAL MARKER BAND WAS MISSING AND THE PROXIMAL MARKER BAND HAD BEEN MOVED. THE USER FACILITY AND CONTACTED AND INDICATED THE MARKER BAND WAS NOT SEEN NO FLUOROSCOPY AS THE PROCEDURE WAS COMPLETED. THEREFORE, THEY CONCLUDED THE MARKER BAND REMAINED IN THE INTRODUCER SHEATH AND WAS DISCARDED. NO ADVERSE EVENTS OR PT INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 106CM 110623024-004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK