BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 1963335 · Received December 15, 2010

    Report

    Report Number
    3006010712-2010-00026
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 2, 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 SPECIFICATION. RESULTS DO NOT INDICATE ANY AREAS OF CONCERN RELATING TO THE STRENGTH OF THE WIRE. NO FURTHER INVESTIGATION IS POSSIBLE AT PRESENT AS THE WIRE HAS YET TO BE RETURNED.

    Description of Event or Problem · 1

    TWO REPORTS DESCRIPTIONS WERE RECEIVED WITH COMPLAINT # (B)(4) CONCERNING A FRACTURED TIP ON A COURIER GUIDEWIRE: (B)(6) CONTACTED TECHNICAL SERVICES TO INITIATE THE REPORT FOR A COURIER WIRE THAT BROKE OFF DURING THE IMPLANT PROCESS. A PORTION WILL BE LEFT IN THE VEIN AND THE OTHER PART WILL BE RETURNED FOR ANALYSIS. (B)(6) WAS IN THE CASE AND WILL CONTACT TECHNICAL SERVICES TO PROVIDE FURTHER INFORMATION. (B)(6) INDICATED IT WAS PRETTY NORMAL USE. THE PHYSICIAN WAS USING AN AIM SL AND DIRECT SL II. THEY WERE PUSHING THE LED FORWARD AND IT PROLAPSED A LITTLE AT THE END. IT APPEARS TO START SHEARING AND WHEN THEY PULLED THE WIRE BACK A FEW CENTIMETERS BROKE OFF. THEY WILL BE RETURNING THE PORTION OF THE WIRE WITH IMAGES TO RETURNED GOODS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT LTD DS2G002 90012222

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN