BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX.014"/205 PLATINUM

    MDR report key: 696081 · Received October 10, 2005

    Report

    Report Number
    6000078-2005-00203
    Event Type
    Malfunction
    Date Received
    October 10, 2005
    Date of Event
    September 9, 2005
    Report Date
    October 7, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC NEUROVASCULAR BECAME AWARE THAT DURING AN EVENT WHEN THE SUBJECT DEVICE WAS INSERTED INTO A GATEWAY BALLOON CATHETER, IT BROKE AT THE DISTAL TIP. NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED WITH THE PT AS A RESULT OF THIS EVENT. THE OPERATION WAS FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX.014"/205 PLATINUM GUIDEWIRE DQX BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV. * 6420101

    Patients

    Seq Age Sex Outcome Treatment
    1 *