BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX .014" / 205 FLOPPY

    MDR report key: 690478 · Received March 17, 2006

    Report

    Report Number
    6000078-2006-00059
    Event Type
    Malfunction
    Date Received
    March 17, 2006
    Date of Event
    January 21, 2006
    Report Date
    March 16, 2006
    Manufacturer
    NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFICE CORPORATION WAS MADE AWARE THAT DURING A PROCEDURE THE PHYSICIAN DOUBTED THAT THE UNIT WAS A TRANSEND EX .014"/205 FLOPPY GUIDEWIRE. NO COMPLICATIONS WITH THE PATIENT WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014" / 205 FLOPPY GUIDEWIRE DQX NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORPORATION * 7859854

    Patients

    Seq Age Sex Outcome Treatment
    1 *