BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROPUNCTURE INTRODUCER SET

    MDR report key: 813119 · Received February 5, 2007

    Report

    Report Number
    MW1041868
    Event Type
    Other
    Date Received
    February 5, 2007
    Date of Event
    December 18, 2006
    Report Date
    February 5, 2007
    Manufacturer
    COOK INCORPORATE
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A COOK MPIS-501 MICROPUNCTURE INTRODUCER SET GUIDE WIRE "UNRAVELED" IN THE PT. THE GUIDEWIRE FRAGMENT IS LOCATED OUTSIDE OF THE VESSEL. IT WAS DETERMINED BY VASCULAR CONSULT TO LEAVE THE FRAGMENT IN THE PT UNLESS NEURO COMPROMISE OR ABSCESS DEVELOPS. PATIENT HAS BEEN FULLY INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE INTRODUCER SET * DYB COOK INCORPORATE MPIS-501 NOT SAVED

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other