BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER II

    MDR report key: 1191823 · Received September 20, 2008

    Report

    Report Number
    1191823
    Event Type
    Malfunction
    Date Received
    September 20, 2008
    Date of Event
    July 8, 2008
    Report Date
    September 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    MECHANICAL FAILURE OF DISTAL TIP OF THE CATHETER. THE CATHETER WAS REPLACED WITH A BRAND NEW ONE. NO HARM OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II CATHETER, EP, ABLATION DRF BOSTON SCIENTIFIC EPT 7F 4MM STANDARD CURVE BLAZER II 11633029

    Patients

    Seq Age Sex Outcome Treatment
    1 *