BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC J3MM 260CM TEF

    MDR report key: 619811 · Received June 22, 2005

    Report

    Report Number
    9616099-2005-01119
    Event Type
    Malfunction
    Date Received
    June 22, 2005
    Date of Event
    March 29, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MKI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMTION APPEARS AVAILABLE DESPITE MULTIPLE ATTEMPTS. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC CARDIAC CATHETERIZATION, A DIAGNOSTIC (.035 IN. X 260 CM -FULL EXCHANGE) GUIDEWIRE FRACTURED AND "COILED" DURING CORONARY ANGIOGRAPHY. THE FRACTURED GUIDEWIRE WAS RETRIEVED AND THE PROCEDURE WAS ABORTED WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW .035 FC J3MM 260CM TEF CARDIOLOGY WIRES & METALS MKI CORDIS DE MEXICO NA F120477

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention