BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCOOP-1 TRANSTRACHEAL CATHETER

    MDR report key: 739 · Received June 22, 1992

    Report

    Report Number
    739
    Event Type
    Death
    Date Received
    June 22, 1992
    Date of Event
    May 30, 1992
    Report Date
    June 3, 1992
    Manufacturer
    TRANSTRACHEAL SYSTEMS, INC.
    Product Code
    CBI
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A 60 YEAR OLD-WHITE FEMALE WITH SEVERE EMPHYSEMA UNDERWENT PLACEMENT OF A TRANSTRACHEAL CATHETER ON APRIL 30, 1992, FOR CHRONIC OXYGEN ADMINISTRATION. IN MID MAY, SHE WAS ADMITTED FO WHAT APPEARED TO BE AN EXACERBATION OF EMPHYSEMA FROM WHICH SHE RECOVERED AND WAS DISCHARGED. ON MAY 30, SHE WAS READMITTED AND ACUTE RESPIRATORY FAILURE REQUIRED INTUBATION AND MECHANICAL VENTILATION. ALTHOUGH SHE INITIALLY IMPROVED, THREE HOURS AFTER ADMISSION AND DURING SUCTIONING BY THE NURSING STAFF, SHE SUDDENLY DETERIORATED AND THE NURSES COULD NOT ADEQUATELY VENTILATE HER. THEY NOTED TREMENDOUS RESISTANCE TO VENTILATION INTIALLY, AND THE PATIENT SUFFERED A BRADYCARDIAC/VENTRICULAR FIBRILLATION CARDIAC ARREST. AUTOSPY REVEALED A 5 X 1.5 X 1.5 CM FIBRIN AND MUCOUS PLUG WITHIN WHICH WAS EMBEDED THE TRANSTRACHEAL CATHETER. THE DISTAL TRACHEA WAS 100% OCCLUDED BY THIS PLUG WHICH WAS PRESUMED TO BE "BALL VALVING", ALLOWING FOR VENTILATION INITIALLY ON THE RESPIRATOR. THE PATIENT HAD BEEN FOLLOWING ALL CATHETER CARE RECOMMEDNED BY THE MANUFACTURER. REVIEW OF THE LITERATURE REVEALS A SINGLE CASE REPORT OF A SIMILAR EVENT ('FATAL AIRWAY OBSTRUCTION CAUSED BY A MUCOUS BALL FROM A TRANSTRACHEAL OXYGEN CATHETER"; CHEST 1991; VOLUME 99:PP 1520-1523). (PHOTO'S AND AUTOPSY REPORT ATTACHED)DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOOP-1 TRANSTRACHEAL CATHETER Implant TRANSTRACHEAL CATHETER CBI TRANSTRACHEAL SYSTEMS, INC. N/A 3091 OR 2521

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death