BEUDAMED
    FDA Adverse Event Death Summary report: N

    BYRD DILATOR SHEATH SET, POLYPROPYLENE

    MDR report key: 280553 · Received June 5, 2000

    Report

    Report Number
    2522007-2000-00014
    Event Type
    Death
    Date Received
    June 5, 2000
    Date of Event
    May 16, 2000
    Report Date
    May 18, 2000
    Manufacturer
    COOK VASCULAR, INC.
    Product Code
    GCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUPERIOR VENA CAVA TEAR AT TIME OF LEAD DETACHMENT FROM VESSEL WALL, RESULTING IN HEMOTHORAX.

    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 50 YR Death