BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 106CM 50CM TZ

    MDR report key: 10729529 · Received October 23, 2020

    Report

    Report Number
    2134265-2020-14525
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 23, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH #(B)(4) THAT A CATHETER LEAK AND CATHETER REPLACEMENT OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS SUCCESSFULLY PLACED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). APPROXIMATELY 3 HOURS LATER, THE PHYSICIAN FOUND A LEAK TO THE CATHETER. THE LEAK WAS OBSERVED TO THE BACK PORT BEFORE THE HUB. AT THIS TIME, THE PATIENT RETURNED TO THE CATHETERIZATION LAB FOR CATHETER REPLACEMENT. THE CATHETER WAS SUCCESSFULLY PLACED WITHOUT FURTHER COMPLICATIONS. PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190176 EKOSONIC KIT 106CM 50CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-55150

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention