BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 10095809 · Received May 28, 2020

    Report

    Report Number
    2134265-2020-07077
    Event Type
    Death
    Date Received
    May 28, 2020
    Date of Event
    May 4, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BTG BOTHELL
    Product Code
    KRA
    UDI-DI
    00858593006134
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A BILATERAL PULMONARY EMBOLISM PROCEDURE. PATIENT HAD HISTORY OF UTERINE CANCER AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 FOR CANCER RELATED SYMPTOMS. ON (B)(6) 2020, PATIENT SENT FOR AN EKSONIC PROCEDURE FOR PULMONARY EMBOLISM (PE) TREATMENT. DURING THE PROCEDURE, PATIENT WAS ON BILEVEL POSITIVE AIRWAY PRESSURE WITH OXYGEN SATURATIONS IN THE MID-80S. PATIENT WAS NOTED TO BE TACHYCARDIC, BUT STABLE. PLACEMENT OF EKOS CATHETER WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT AND INFUSIONS STARTED IN THE LAB. PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AND 5 MINUTES AFTER ARRIVAL, PATIENT WENT INTO CARDIOPULMONARY ARREST. AT THIS TIME, CHEST COMPRESSIONS WERE PERFORMED WITH A CARDIOPULMONARY ASSIST MACHINE FOR 20 MINUTES TO STABILIZE THE PATIENT. APPROXIMATELY 10 MINUTES LATER, PATIENT BECAME BRADYCARDIC AND A SECOND CARDIOPULMONARY ARREST OCCURRED. PATIENT WAS THEN TREATED FOR THE NEXT 40 MINUTES BEFORE EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562982 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA BTG BOTHELL 500-55112 0190702070 00858593006134

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death