BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 924531 · Received October 3, 2007

    Report

    Report Number
    MW5003990
    Event Type
    Injury
    Date Received
    October 3, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 3, 2007
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURE AND RETENTION OF APPROXIMATELY 4MM OF ABBOTT VASCULAR CONFIANZA PRO 12 PTCA GUIDEWIRE TIP IN DIAGONAL BRANCH VESSEL DURING UNSUCCESSFUL PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. CONFIANZA PRO 12 061011A161

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other