BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCOOP-1

    MDR report key: 109387 · Received July 28, 1997

    Report

    Report Number
    1721097-1997-00001
    Event Type
    Death
    Date Received
    July 28, 1997
    Date of Event
    June 26, 1997
    Manufacturer
    TRANSTRACHEAL SYSTEMS, INC.
    Product Code
    BTO
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    PT WITH PULMONARY FIBROSIS AND SCOOP TRANSTRACHEAL PROCEDURE FOR SUPPLEMENTAL OXYGEN THERAPY PERFORMED ON JUNE, 19, 1997, TO IMPROVE EFFICIENCY OF BLOOD OXYGEN SATURATION LEVELS. ON JUNE 22, 1997, PT WAS ADMITTED TO HOSP EMERGENCY WITH DIAGNOSIS OF PRE-EXISTING PULMONARY HYPERTENSION AND CHRONIC RESPIRATORY FAILURE: SUPPLEMENTAL OXYGEN DELIVERY VIA A NASAL CANULA AT 4 LPM WITH PO2=38, PCO2=36, PH=7.41; PRE-SCOOP STENT (NON-FUNCTIONAL) WAS IN PLACE. ON JUNE 25, 1997, STENT WAS REMOVED AND SCOOP-1 WAS PLACED TO INITIATE TRANSTRACHEAL OXYGEN DELIVERY. ON JUNE 26, 1997, AT 0400 HRS. PT WAS NOTED TO BE BRADYCARDIA, ATROPHINE WAS GIVEN WITH NEGATIVE EFFECT, AND PT WAS UNRESPONSIVE TO VERBAL/PHYSICAL STIMULI. THE BEAD CHAIN NECKLACE USED TO SECURE THE SCOOP-1 CATHETER HAD NOT BEEN TAPED TO THE PT WHICH ALLOWED INADVERTENT DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOOP-1 Implant TRANSTRACHEAL OXYGEN CATHETER BTO TRANSTRACHEAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1