BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 1963332 · Received December 15, 2010

    Report

    Report Number
    3006010712-2010-00027
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 3, 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

    A REVIEW OF MANUFACTURING RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. RESULTS DO NOT INDICATE ANY AREAS OF CONCERN RELATING TO THE STRENGTH OF THE WIRE. NO FURTHER INVESTIGATION IS POSSIBLE AS THE WIRE WAS NOT RETURNED. 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). 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 INFORMATION PROVIDED. AS THE DEVICE WAS NOT RETURNED IT IS IMPOSSIBLE TO EVALUATE THE MATERIAL CONDITION OF THE WIRE. COMPLAINT HISTORY FOR THIS DEVICE HAS BEEN INVESTIGATED.

    Description of Event or Problem · 1

    REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT A GUIDEWIRE GOT STUCK IN THE 1258T LEAD DURING IMPLANT. PHYSICIAN TRIED TO PULL THE GUIDEWIRE OUT AND THE DISTAL TIP OF THE WIRE BROKE OFF IN THE LEAD. REPRESENTATIVE STATED THAT ABOUT 2CM WERE LEFT IN THE LEAD. THE LEAD REMAINS IMPLANTED. SYSTEM REMAINS IN THE FIELD AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT LTD DS2G002 90012383

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK