BEUDAMED
    FDA Adverse Event Death Summary report: N

    #16 FRENCH PERCUTANEOUS INTRODUCER KIT

    MDR report key: 6185 · Received August 9, 1993

    Report

    Report Number
    6185
    Event Type
    Death
    Date Received
    August 9, 1993
    Date of Event
    March 26, 1992
    Report Date
    July 19, 1993
    Manufacturer
    DAVOL, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT IN SURGERY FOR PLACEMENT OF HICKMAN CATHETER IN RIGHT SUBCLAVIAN VEIN. 16 FRENCH PERCUTANEOUS INTRODUCER KIT USED TO PLACE. GUIDEWIRE REMOVED AND BRIGHT RED BLOOD SPILLED OUT OF SITE UNDER PRESSURE. RESUSCIATIVE ACTIONS MET WITH NEGATIVE RESULTS.POST MORTUM AUTOPSY INDILATES: PERFORATION OF LEFT SUBCLAVIAN VEIN; PERFORATION OF LEFT COMMON CAROTID ARTERY, HEMORRAGE INTO SOFT TISSUES WITH MEDIASTINUM. CAUSE OF DEATH: EXSANGUINATION, DUE TO VASCULAR TRAUMA FROM MEDICAL APPLIANCE. ACCIDENT - THERAPEUTIC MISADVENTUREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, OTHER. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #16 FRENCH PERCUTANEOUS INTRODUCER KIT DYB DAVOL, INC. 45G9KA31

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death