BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUTION 9 FRENCH MECHANICAL DILATOR SHEATH SET

    MDR report key: 1206484 · Received October 14, 2008

    Report

    Report Number
    1206484
    Event Type
    Death
    Date Received
    October 14, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 14, 2008
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED LEAD EXTRACTION USING EVOLUTION MECHANICAL DILATOR SHEATH SET. SVC WAS DAMAGED CAUSING IRREVERSIBLE HEMORRHAGE, PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLUTION 9 FRENCH MECHANICAL DILATOR SHEATH SET CARDIAC LEAD EXTRACTION SHEATH DRE COOK VASCULAR INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death