BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUGAR LS STEERABLE GUIDEWIRE HYDRO-TRACK

    MDR report key: 1210107 · Received October 17, 2008

    Report

    Report Number
    1220452-2008-00068
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTORNIC INC
    Product Code
    DQX
    PMA / PMN Number
    K032899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE TIP OF THE GUIDE WIRE SEPARATED FROM THE SHAFT AND BECAME LODGED INTO THE PT'S VESSEL AND WAS SUCCESSFULLY REMOVED FROM THE PT. THE PHYSICIAN INSERTED THE GUIDE WIRE INTO THE PT WITH A LEFT VENTRICLE LEAD FOR IMPLANTATION. THE PHYSICIAN HAD DIFFICULTY WITH SUPPORT THE PLACING THE LEAD. THE PHYSICIAN ADVANCED WITH TIP OF THE GUIDE WIRE THROUGH THE TIP AREA OF THE LEAD AND ATTEMPTED TO FIND THE OPTIMAL VEIN BRANCH WITH THE GUIDE WIRE. AT SOME POINT THE TIP OF THE GUIDE WIRE BECAME SEPARATED FROM THE SHAFT. THE GUIDE WIRE SEPARATED TIP BECAME LODGED INSIDE THE PROXIMAL PART OF THE PULMONARY ARTERY. THE PHYSICIAN CONTINUED THE CASE AND SUCCESSFULLY IMPLANTED THE LEAD. THE PHYSICIAN WITH HELP FROM CLINICAL SPECIALISTS WERE ABLE TO SUCCESSFULLY REMOVE THE SEPARATED GUIDE WIRE TIP FROM THE PT. THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUGAR LS STEERABLE GUIDEWIRE HYDRO-TRACK DQX MEDTORNIC INC NA 0000712145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA