BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX .014"/205 FLOPPY

    MDR report key: 445235 · Received February 24, 2003

    Report

    Report Number
    6000078-2003-00008
    Event Type
    Malfunction
    Date Received
    February 24, 2003
    Date of Event
    January 9, 2003
    Report Date
    February 24, 2003
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIC/TARGET WAS NOTIFIED THAT UPON SECOND USE IN THE PATIENT THE TRANSEND EX .014"/205 FLOPPY BROKE IN TWO PIECES. THERE WAS NO INJURY REPORTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014"/205 FLOPPY GUIDEWIRE DQX TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION * 5135193

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO