BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .008" MIRAGE HYDROPHYLIC GUIDEWIRE

    MDR report key: 3699227 · Received March 25, 2014

    Report

    Report Number
    2029214-2014-00163
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 26, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE CUSTOMER HAD TWO LOT NUMBERS, BUT WAS NOT SURE WHICH LOT NUMBER BELONGED TO THE DEVICE IN QUESTION. THEREFORE, BOTH LOT NUMBERS WERE PROVIDED AND THEY ARE AS FOLLOWS: MODEL: 103-0608 / LOT: 9703805 DOM: 02/06/2013 EXP: 10/31/2015; MODEL: 103-0608 / LOT: 9712011 DOM: 02/25/2013 EXP: 11/01/2015. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AV (ARTERIOVENOUS) FISTULA. DURING THE PROCEDURE, IT WAS REPORTED THE MIRAGE GUIDEWIRE COULD NO LONGER BE SEEN; THEREFORE, THE PHYSICIAN ATTEMPTED TO PULL BACK THE GUIDEWIRE BUT WITHOUT SUCCESS. THEN THE PHYSICIAN PULLED HARDER AND TORQUED THE GUIDEWIRE TO MAKE MORE ROOM IN THE CATHETER LUMEN, BUT THE TIP OF THE GUIDEWIRE SEPARATED (10CM-15CM). THE GUIDEWIRE ALONG WITH ALL BROKEN SEGMENTS AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW MIRAGE GUIDEWIRE WITHOUT ISSUES. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174538 .008" MIRAGE HYDROPHYLIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1