BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE GUIDEWIRE

    MDR report key: 2072672 · Received April 29, 2011

    Report

    Report Number
    2134265-2011-01429
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR AN UNSPECIFED PROCEDURE, THE GUIDE WIRE BROKE.THE PHYSICIAN NOTED THAT DURING PREPARATION OUTSIDE OF THE PATIENT'S BODY, THE GUIDE WIRE BROKE ABOUT MID WAY ON THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7491213501J1

    Patients

    Seq Age Sex Outcome Treatment
    1