BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 11984357 · Received June 11, 2021

    Report

    Report Number
    2134265-2021-07541
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 11, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006028
    PMA / PMN Number
    K182324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRUG OCCLUSION AND LEAK OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A LOWER EXTREMITY ARTERIAL THROMBOLYSIS PROCEDURE. APPROXIMATELY 7 HOURS INTO THERAPY, BLOOD WAS NOTED IN THE DRUG PORT. THE LYTIC BAG WAS CHANGED AN HOUR BEFORE. TROUBLESHOOTING WAS PERFORMED AND A LEAK FROM THE THREE WAY STOPCOCK WAS NOTED. THE NURSE ATTEMPTED TO FLUSH WITH A 3 CC SYRINGE, BUT WAS UNSUCCESSFUL. BACK PRESSURE WAS RELEASED AND ANOTHER FLUSH WAS ATTEMPTED FOR NO RESOLUTION. AT THIS TIME, THE PHYSICIAN DECIDED TO SEND THE PATIENT BACK FOR RECHECK. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878684 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-55106 0011700105 00858593006028

    Patients

    Seq Age Sex Outcome Treatment
    1