BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 135CM 50CM TZ

    MDR report key: 11686352 · Received April 19, 2021

    Report

    Report Number
    2134265-2021-04987
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    February 5, 2021
    Report Date
    April 19, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006318
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALL MSD GROUPS DISABLED ALERT WAS CONFIRMED THROUGH EVENT LOG AND DEVICE ANALYSIS. THE EVIDENCE OF THE RF DRIFT ON THE CONTROL UNIT (CU) LIKELY ACCELERATED WEAR ON THE ULTRA SONIC CORE (USC). THE CHAR SEEN ON THE USC POINTS TO A SHORT AND FAILURE OF ONE OF THE TRANSDUCER ELEMENTS IN THE USC. IT APPEARS THE SHORTING IN THE USC MAY HAVE CONTRIBUTED TO THE FAILURE AND EVENTUAL FRACTURE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ULTRASONIC CORE FRACTURE OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS PROCEDURE. DURING THE PROCEDURE AN ALL MSD GROUPS DISABLED ALARM OCCURRED. THE ALARM WAS UNABLE TO BE RESOLVED; THEREFORE, THE PROCEDURE WAS COMPLETED BY RUNNING THE CATHETER AS A STANDARD INFUSION CATHETER. UPON RECHECK THE FOLLOWING DAY, IT WAS DISCOVERED THAT THE ULTRASONIC CORE WIRE HAD BROKE INSIDE THE PATIENT. THE CATHETER WAS SUCCESSFULLY SNARED OUT WITH A NON-BSD SNARE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583080 EKOSONIC KIT 135CM 50CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-56150 0010790333 00858593006318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention