BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK

    MDR report key: 2030839 · Received March 22, 2011

    Report

    Report Number
    MW5019925
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 22, 2011
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF IR PROCEDURE, M.D. WAS IN THE PROCESS OF PULLING THE VASCULAR SHEATH WHEN THE SHEATH FRACTURED AND A 3CM PIECE OF IT WAS LEFT IN THE PATIENT'S VESSEL (L AV FISTULA). SURGEON PERFORMED A SURGICAL CUT DOWN AND REMOVED THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK 6F CHECK-FLO PERFORMER INTRODUCER DYB COOK INCORPORATED RYCFW-6.0-35-6-RB-C 2556552

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR