BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 11612689 · Received April 5, 2021

    Report

    Report Number
    2134265-2021-04202
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    June 25, 2017
    Report Date
    April 5, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CARDIAC ARREST OCCURRED. ON (B)(6) 2017, THE SUBJECT WAS ENROLLED IN THE RETROSPECTIVE COHORT OF THE KNOCKOUT PE TRIAL AND INDEX PROCEDURE WAS INITIATED ON THE SAME DAY. THE LESION WAS IDENTIFIED IN RIGHT LOWER LOBAR ARTERY AND THE CATHETER WAS PLACED IN THE RIGHT JUGULAR VEIN. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INFUSED AT A RATE OF 2 MG/HR FOR A TOTAL DOSE OF 12MG. DURING THE PROCEDURE, PATIENT SUSTAINED A CARDIAC ARREST WITH ASSOCIATED HYPOTENSION, DYSPNEA AND ALTERED MENTAL STATUS. AT THIS TIME, PATIENT WAS INTUBATED AND UNDERWENT CARDIOPULMONARY RESUSCITATION (CPR) PROCEDURE. THE EVENT WAS CONSIDERED RESOLVED THAT DAY. ON (B)(6) 2017, PATIENT WAS DISCHARGED HOME. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512787 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention