BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.035" HYBRID WIRE, BOX OF 5

    MDR report key: 7052792 · Received November 22, 2017

    Report

    Report Number
    2951238-2017-00742
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 22, 2017
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    EYA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DISCARDED THE DEVICE AFTER THE PROCEDURE; THEREFORE, NO EVALUATION WILL BE PERFORMED. THE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. THIS TYPE OF GUIDEWIRE DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING AND CAUTION STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE GUIDEWIRE. "DO NOT APPLY EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED, DETERMINE THE CAUSE AND TAKE REMEDIAL ACTION BEFORE CONTINUING. WHEN USING A MOVEABLE CORE GUIDEWIRE, DO NOT ATTEMPT TO ADVANCE, STIFFEN OR STRAIGHTEN THE TIP OF THE GUIDEWIRE AGAINST RESISTANCE. DO NOT RESHAPE OR ALTER THE CONFIGURATION OF THE GUIDEWIRE. DOING SO MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE GUIDEWIRE AND MAY RESULT IN COMPLICATIONS. "

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, WHILE THE SURGEON WAS INSERTING THE STENT THE GUIDEWIRE BROKE AND BEGAN TO UNCOIL IN THE PATIENT. IT WAS REPORTED THAT NO DEVICE FRAGMENT FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE GUIDEWIRE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME GUIDEWIRE. THE PROCEDURE WAS NOT DELAYED. THE PATIENT WAS DISCHARGE IN STABLE CONDITION. ADDITIONALLY, THE GUIDEWIRE WAS INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831077 0.035" HYBRID WIRE, BOX OF 5 0.035" HYBRID WIRE EYA GYRUS ACMI, INC GWH3505R UNKNWON

    Patients

    Seq Age Sex Outcome Treatment
    1