BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC KIT 135CM 50CM TZ

    MDR report key: 11787252 · Received May 6, 2021

    Report

    Report Number
    2134265-2021-05882
    Event Type
    Death
    Date Received
    May 6, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BTG BOTHELL
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIBE EVENT OR PROBLEM - UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT EXPIRED. A PERIPHERAL ARTERIAL OCCLUSION PROCEDURE WAS PERFORMED USING TWO EKOSONIC 135CM 50CM TZ CATHETERS AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THE TIME OF THIS REPORT. IT WAS FURTHER REPORTED THE PATIENT PRESENTED WITH THROMBUS IN THE AORTA EXTENDING DOWN BOTH ILIAC INTO THE SUPERFICIAL FEMORAL ARTERIES (SFA). THE INITIAL INTERVENTION WAS DONE TO REMOVE THE THROMBUS FROM THE AORTA AND BOTH ILIAC VESSELS WITH NON BSC DEVICES. THE PATIENT CAME BACK FOR FOLLOW-UP INTERVENTION AND TWO EKOS CATHETERS WERE THEN PLACED ARTERIAL BILATERAL, THERAPY WAS STARTED AND RAN FOR LESS THAN 4 HOURS PATIENT WENT INTO CARDIAC ARREST, BELIEVED TO BE RELATED TO THROMBUS THROUGHOUT THE PATIENT'S BODY, AND DIED. THE PHYSICIAN STATED EKOS WAS NOT RELATED TO THE PATIENT'S DEATH. THE PATIENT HAD A MASSIVE AMOUNT OF THROMBUS THROUGHOUT HIS BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPIRED. A PERIPHERAL ARTERIAL OCCLUSION PROCEDURE WAS PERFORMED USING TWO EKOSONIC 135CM 50CM TZ CATHETERS AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680699 EKOSONIC KIT 135CM 50CM TZ CATHETER, CONTINUOUS FLUSH KRA BTG BOTHELL 500-56150

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death