BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX .014"/205 PLATINUM

    MDR report key: 546340 · Received September 27, 2004

    Report

    Report Number
    6000078-2004-00156
    Event Type
    Malfunction
    Date Received
    September 27, 2004
    Date of Event
    August 10, 2004
    Report Date
    September 23, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED THAT THE TRANSEND EX .014"/205 PLATINUM GUIDEWIRE BROKE. NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED WITH THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014"/205 PLATINUM GUIDEWIRE DQX BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV. * 6663504

    Patients

    Seq Age Sex Outcome Treatment
    1 *