BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME

    MDR report key: 3112133 · Received August 17, 2006

    Report

    Report Number
    6000048-2006-00475
    Event Type
    Malfunction
    Date Received
    August 17, 2006
    Date of Event
    July 12, 2006
    Report Date
    July 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC SPENCER
    Product Code
    ODD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL YET. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECS. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    AN AUTOTOME WAS USED FOR THERAPEUTIC PURPOSES. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME CANNULATING ODD BOSTON SCIENTIFIC SPENCER 8509963

    Patients

    Seq Age Sex Outcome Treatment
    1