BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUGAR XT HYDROPHILIC 300

    MDR report key: 2121356 · Received June 6, 2011

    Report

    Report Number
    1220452-2011-00043
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 20, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQX
    PMA / PMN Number
    K032899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT HAS INDICATED THAT THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD WILL BE CONDUCTED. DEVICE DISCARDED - NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    MEDWATCH REPORT - MW5020397 - (B)(6) HOSPITAL. THE MAUDE EVENT REPORT INDICATES THE FOLLOWING: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO LEFT LOWER EXTREMITY WAS BEING PERFORMED. THE GUIDE WIRE BROKE IN THE SUPERFICIAL FEMORAL ARTERY WHILE REMOVING. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE GUIDE WIRE BUT WAS UNSUCCESSFUL. THE GUIDE WIRE WAS SECURED IN THE VESSEL WITH STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUGAR XT HYDROPHILIC 300 DQX MEDTRONIC INC. NA GB901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention