BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER

    MDR report key: 35481 · Received July 2, 1996

    Report

    Report Number
    35481
    Event Type
    Death
    Date Received
    July 2, 1996
    Report Date
    June 30, 1996
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DYB
    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

    PT WAS FOUND ON FLOOR NEXT TO HIS BED WITH AGONAL RESPIRATIONS, SURROUNDED BY A POOL OF BLOOD ABOUT HIS HEAD AND BODY-APPROX 2-3 LITERS. THE PERCUTANEOUS INTRODUCER SHEATH IN PT'S RIGHT INTERNAL JUGULAR VEIN FOUND TO BE LOOSE WITH BLOOD EXSANGUINATING. THE SHEATH WAS RECAPPED/SCREWED BACK ON IMMEDIATELY. CPR WAS INITIATED WITH ALL MEASURES TAKEN. AFTER APPROX. 50 MINUTES, PT WAS ASYSTOLIC AND PRONOUNCED DEAD. THE PT AND INTRODUCER SHEATH (IV LINE) WERE OBSERVED WITH NO PROBLEMS NOTED 28 MINUTES PRIOR TO THIS EVENT. TPN HAD BEEN INFUSING IN THIS LINE WITH NO PRIOR LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS SHEATH INTRODUCER PERCUTANEOUS SHEATH INTRODUCER DYB ARROW INTERNATIONAL, INC. AK-09701 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death