BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 1934272 · Received November 24, 2010

    Report

    Report Number
    3006010712-2010-00025
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K073082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS SHOWED THAT THE DEVICE WAS MFG TO SPECIFICATION. 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.

    Description of Event or Problem · 1

    THE CPS COURIER GUIDEWIRE COULD NOT BE REMOVED FROM THE QUICKSITE MICRO LEAD. WHILST TRYING TO PULL THE WIRE OUT, THE TIP OF THE WIRE BROKE OFF. FORTUNATELY THE TIP OF THE WIRE STUCK TO THE TIP OF THE LEAD WHEN IT WAS REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. DS2G001 90014798

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK