BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DGW .038 FC J3MM 150CM TEF

    MDR report key: 774676 · Received October 27, 2006

    Report

    Report Number
    1016427-2006-00108
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    October 3, 2006
    Report Date
    October 27, 2006
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MKI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS, BUT THE EVALUATION AND TESTING HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC PROCEDURE, THE DISTAL TIP OF A .038 J3MM 150CM GUIDEWIRE SEPARATED. AN ULTRASOUND REVEALED THAT THE TIP WAS IN THE LUMEN OF THE RIGHT FEMORAL ARTERY. A VASCULAR SURGEON WAS CALLED, AND THE PT UNDERWENT SURGICAL PROCEDURE TO REMOVE THE SEPARATED PIECE. HOWEVER, DURING THE SURGERY, THE DISTAL TIP WAS NOTED IN THE SUBCUTANEOUS TISSUE AND WAS EASILY REMOVED. THE PT WAS HOSPITALIZED FOR TWO DAYS AND THE CATHETERIZATION PROCEDURE WAS RE-SCHEDULED. CURRENTLY, THE PT IS IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW .038 FC J3MM 150CM TEF CARDIOLOGY WIRES & METALS MKI CORDIS CORPORATION NA F0606742

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R