BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND 300 FLOPPY

    MDR report key: 1013070 · Received February 27, 2008

    Report

    Report Number
    1013070
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    December 6, 2007
    Report Date
    February 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DOING AN ANEURYSM COILING. HE ADVANCED THE TRANSEND 300 FLOPPY GUIDEWIRE THROUGH A MICROCATH, TOOK THE MICROCATH OFF AND ADVANCED A NEUROFORM STENT OVER THE WIRE. THOUGH THE PHYSICIAN NOTED IT FELT TIGHT, THE STENT WAS ADVANCED. THE DOCTOR THEN DEPLOYED THE STENT AND TRIED TO PULL IT OFF, BUT IT WAS VERY DIFFICULT. THE DOCTOR ALSO FOUND IT DIFFICULT TO MANIPULATE THE WIRE WITHIN THE STENT. EVENTUALLY, THE PHYSICIAN HAD TO PULL FORCEFULLY TO GET THE STENT OFF THE WIRE. AFTER THE WIRE WAS REMOVED, EXAMINATION REVEALED THAT THE WIRE WAS STRETCHED, AND THAT PART OF THE WIRE COATING SEEMED TO BE MISSING. THE PATIENT WAS NOT HARMED AS A RESULT, AND THERE HAS BEEN NO RESPONSE FROM THE MANUFACTURER REGARDING THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND 300 FLOPPY GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION * 11165280

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR