BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL

    MDR report key: 1103343 · Received August 7, 2008

    Report

    Report Number
    MW5007924
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    July 22, 2008
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF COOK MEDICAL 6F/55CM CHECK FLO SHEATH THE END OF SHEATH FRACTURED LEAVING PIECE OF DEVICE IN ARTERY, REQUIRING EMERGENT CARDIOVASCULAR SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MEDICAL CHECK FLO SHEATH DYB COOK MEDICAL G09809 2079813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R