BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 1931281 · Received November 8, 2010

    Report

    Report Number
    3006010712-2010-00022
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    May 31, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BRIVANT LTD.
    Product Code
    DQX
    PMA / PMN Number
    K073082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS AND CONCLUSION: THE ANALYSIS OF THE LOT HISTORY RECORDS DOES NOT INDICATE ANY AREAS OF CONCERN RELATING TO THE STRENGTH OF THE WIRE. GUIDEWIRES ARE DELICATE DEVICES AND CAN FRACTURE IF THEIR TENSILE LIMITS ARE EXCEEDED DURING A PROCEDURE (E.G. WHEN A WIRE BECOMES SNAGGED OR TRAPPED). THE IMAGES OF THE DEVICE SUGGEST THAT THE DEVICE WAS MANIPULATED QUITE SEVERELY AROUND THE FRACTURE AREA. THERE IS EVIDENCE OF A "HOOK" SHAPE WHICH MAY INDICATE THAT THE DEVICE HAD BEEN SNAGGED AND MANIPULATED IN AN ATTEMPT TO FREE THE DEVICE. CAUTIONS AGAINST ROBUST USE OF THE GUIDEWIRE ARE OUTLINED IN THE DFU. IT IS ADVISED IN THE DFU NOT TO MANIPULATE THE GUIDEWIRE IF RESISTANCE IS ENCOUNTERED, TO WITHDRAW AND INSPECT THE GUIDEWIRE FOR SIGNS OF DAMAGE AND NOT TO REINTRODUCE THE GUIDEWIRE IF IT APPEARS DAMAGED OR KINKED. IT IS DIFFICULT IF NOT IMPOSSIBLE TO ASCERTAIN THE CLINICAL CONDITIONS AT THE TIME OF FRACTURE DUE TO THE LIMITED AMOUNT OF INFO PROVIDED.

    Description of Event or Problem · 1

    GUIDEWIRE TIP BROKE OFF DURING POSITIONING OF THE LV LEAD IN A POSTERO-LATERAL BRANCH. THE TIP BROKE AT APPROX 2 CM FROM THE DISTAL PART OF THE GUIDEWIRE. THE PART THAT BROKE OFF WAS REMOVED BY A GRABBING TOOL DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT LTD. DS2G002 90015049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK