BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK INCORPORATED

    MDR report key: 531311 · Received June 2, 2004

    Report

    Report Number
    MW1032291
    Event Type
    Injury
    Date Received
    June 2, 2004
    Date of Event
    May 24, 2004
    Report Date
    June 2, 2004
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN THE CATH LAB FOR PTA OR LEFT SFA. PTA WENT SMOOTHLY AND WHEN TRYING TO REMOVE CATHETER, CATHETER UNCOILED AND BROKE APART IN ARTERY. PT WAS TAKEN TO SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INCORPORATED FLEXOR CHECK-FLO PERFORMER INTRODUCER SET DYB COOK INCORPORATED KCFW-7.0-38-55-RB-RA 1360316

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention