BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC J3MM 150CM TEF

    MDR report key: 821367 · Received January 24, 2007

    Report

    Report Number
    1016427-2007-00007
    Event Type
    Malfunction
    Date Received
    January 24, 2007
    Date of Event
    December 22, 2006
    Report Date
    December 29, 2006
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MKI
    PMA / PMN Number
    k864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER REMOVING THE GUIDEWIRE FROM THE PACKAGE, IT WAS NOTICED THAT THE TIP OF THE WIRE WAS BROKEN. THERE WAS NO SEPARATION. THE PRODUCT WAS NOT CLINICALLY USED, AS THE DEFECT WAS NOTED PRIOR TO USE. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. AS NO STERILE LOT NUMBER WAS AVAILABLE, NEITHER A DEVICE HISTORY REVIEW NOR A LOT HISTORY COULD BE PERFORMED. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, USER-HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW .035 FC J3MM 150CM TEF CARDIOLOGY WIRES & METAL (DQX) MKI CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA