BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-PEDION HYDROPHYLIC GUIDEWIRE

    MDR report key: 3032979 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00308
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE WAS RETURNED FOR EVALUATION AND IT WAS FOUND TO BE BROKEN WITH THE BROKEN DISTAL SEGMENT MISSING. CROSS SECTIONAL ANALYSIS OF THE BREAK POINT INDICATED THAT THE FAILURE MODE WAS LIKELY DUE TO DUCTILE OVERLOAD. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN TWISTED THE X-PEDION GUIDEWIRE SEVERAL TIMES CAUSING IT TO FOLD UPON ITSELF AND BREAKING THE TIP. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN SEGMENT FROM THE PATIENT BY BRINGING THE CATHETER OVER THE TIP. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136689 X-PEDION HYDROPHYLIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0605-200 9585295

    Patients

    Seq Age Sex Outcome Treatment
    1