BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 11990694 · Received June 14, 2021

    Report

    Report Number
    2134265-2021-07578
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 14, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006134
    PMA / PMN Number
    K182324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A BILATERAL PULMONARY EMBOLISM THROMBOLYSIS PROCEDURE. TREATMENT HAD BEEN RUNNING FOR OVER 24 HOURS. IT WAS NOTED THAT SANGUINEOUS FLUID WAS LEAKING FROM THE STRAIN RELIEF, AND PROGRESSIVELY WORSENED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889814 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-55112 0011324571 00858593006134

    Patients

    Seq Age Sex Outcome Treatment
    1