BEUDAMED
    FDA Adverse Event Death Summary report: N

    BYRD DILATOR SHEATH SET, POLYPROPYLENE

    MDR report key: 285881 · Received July 14, 2000

    Report

    Report Number
    2522007-2000-00019
    Event Type
    Death
    Date Received
    July 14, 2000
    Date of Event
    June 16, 2000
    Report Date
    July 3, 2000
    Manufacturer
    COOK VASCULAR, INC.
    Product Code
    GCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DEATH DUE TO MASSIVE EXSANGUINATION DUE TO PERFORATED SUPERIOR VENA CAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BYRD DILATOR SHEATH SET, POLYPROPYLENE CATHETER RETRIEVAL DEVICE GCC COOK VASCULAR, INC. LR-PPLBES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death STEEL DILATOR SHEATH SET.| LOCKING STYLET AND BYRD TELESCOPING STAINLESS