BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC J3MM 150CM TEF

    MDR report key: 300312 · Received October 12, 2000

    Report

    Report Number
    1016427-2000-00197
    Event Type
    Malfunction
    Date Received
    October 12, 2000
    Date of Event
    July 6, 2000
    Report Date
    October 12, 2000
    Manufacturer
    CORDIS CORP (MIAMI)
    Product Code
    MKI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GUIDEWIRE WAS NOTED FRACTURED WITHIN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW .035 FC J3MM 150CM TEF CARDIOLOGY WIRES & METALS MKI CORDIS CORP (MIAMI) NA F0300785

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN