BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DGW .035 MC J3MM 150CM TEF AMP

    MDR report key: 619321 · Received June 29, 2005

    Report

    Report Number
    1016427-2005-00172
    Event Type
    Injury
    Date Received
    June 29, 2005
    Date of Event
    May 30, 2005
    Report Date
    June 29, 2005
    Manufacturer
    CORDIS CORPORATION (MIAMI)
    Product Code
    MKI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS PRESENTED TO THE CATHLAB FOR A CARDIAC CATHETERIZATION. THE VESSEL WAS DESCRIBED AS NORMAL. A JR4 GUIDE CATHETER WAS USED IN THE PROCEDURE. UPON REMOVAL OF THE GUIDEWIRE IT IS REPORTED THAT THE "INNER CORE" SEPARATED FROM THE OUTER BODY OF THE GUIDEWIRE AND WAS MANUALLY RETRIEVED BY THE SCRUB TECH. THERE WERE NO KINKS OR BENDS NOTICED IN THE GUIDE WIRE AND THERE WAS NOTHING UNUSUAL NOTICED ABOUT THE GUIDWIRE WHEN IT WAS TAKEN OUT OF THE PACKAGE AND PREPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE OF THE SAME BRAND. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW .035 MC J3MM 150CM TEF AMP ENDOVASCULAR WIRES & METALS MKI CORDIS CORPORATION (MIAMI) NA N1204177

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening