BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8415477 · Received March 13, 2019

    Report

    Report Number
    1646848-2019-00001
    Event Type
    Death
    Date Received
    March 13, 2019
    Report Date
    January 10, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS AVAILABLE, IT WAS NOT POSSIBLE TO DETERMINE ROOT CAUSE OF THE EVENT. INVOLVEMENT OF THE ORIGEN CATHETER IN THE EVENT WAS NEITHER CONFIRMED NOR RULED OUT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS CASE, ORIGEN WILL REOPEN THE COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    PERFORATION OF THE RIGHT ATRIUM WHILE USING A 23 FRENCH DUAL LUMEN CATHETER. DR. (B)(6) REPORTED THAT THE PATIENT DIED OF CARDIAC TAMPONADE AND AN AUTOPSY FOUND THREE PERFORATIONS IN THE RIGHT ATRIUM. THERE WAS DIFFICULTY IN SEEING THE CATHETER ON ULTRASOUND AND HEALTHCARE TEAM WAS NOT CERTAIN IF THE CATHETER HAD BEEN PLACED TOO LOW. THE CANNULATING SURGEON REPORTED THAT HE FELT HE MAY HAVE INSERTED THE GUIDEWIRE TOO DEEPLY AND THE ULTRASOUND OPERATOR HAD A GREAT DEAL OF DIFFICULTY IN LOCATING THE CATHETER IN THE ATRIUM. DR. (B)(6) THOUGHT THE ATRIAL PUNCTURE COULD HAVE OCCURRED FROM EITHER INITIAL CANNULATION OR MIS-POSITIONING OF THE CATHETER LATER, BUT SHE DID NOTE THAT THE LEAKAGE WAS NOT NOTICED UNTIL LATE IN THE CASE. SHE THOUGHT THE RE-POSITIONING OF THE PATIENT MAY HAVE PLAYED A ROLE AS WELL. DR. (B)(6) INDICATED THAT THE LEAKAGE SEEMED TO HAVE CAUSED TAMPONADE, AND NOTED THAT THIS COULD POSSIBLY HAVE COME FROM A SLOW LEAK STARTED AT CANNULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209628 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC. VV23F

    Patients

    Seq Age Sex Outcome Treatment
    1 Death