BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCOOP TRANSTRACHEAL OXYGEN CATHETER

    MDR report key: 106702 · Received July 15, 1997

    Report

    Report Number
    106702
    Event Type
    Death
    Date Received
    July 15, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 10, 1997
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED 6/22/97 VIA EMERGENCY DEPT. WITH IPF (PULMONARY FIBROSIS), PULMONARY HYPERTENSION, CHRONIC RESPIRATORY FAILURE. PO2 38 PCO2 36. PH7.41 ON 4L NC. A SCOOP CATHETER WAS PLACED ON JUNE 19, 1997. ON 6/25/97, A SCOOP-1 CATHETER WAS PLACED. ON 6/26/97 AT 0400, PATIENT WAS NOTED TO BE BRADYCARDIC. ATROPINE WAS GIVEN WITH NO RESPONSE. PATIENT WAS UNRESPONSIVE TO VERBAL/PHYSICAL STIMULI. SCOOP CATHETER WAS FOUND OUT OF TRACHEA AND LYING ON NECK. PATIENT STATUS WAS "NO CODE". PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOOP TRANSTRACHEAL OXYGEN CATHETER Implant OXYGEN DELIVERY CATHETER BTO TRANSTRACHEAL SYSTEMS * 940307

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death