BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY LONG

    MDR report key: 1241795 · Received November 18, 2008

    Report

    Report Number
    9616666-2008-00006
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    November 4, 2008
    Manufacturer
    CLEAR STREAM
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WITH MARKER BAND PLACEMENT HAS BEEN IDENTIFIED AND IMPROVEMENTS HAVE BEEN PUT IN PLACE. ALL LOTS FROM WITH AN EXPIRY DATE OF THE 1ST OF JULY 2011 ONWARDS WILL INCORPORATE THESE IMPROVEMENTS. PREVIOUSLY, THE MARKER BAND WAS PLACED ACCORDING TO THE DISTAL CONE OF THE BALLOON. DUE TO THE LARGER TOLERANCE ON 120MM AND LONGER BALLOONS, THIS ALLOWED FOR THE POSSIBILITY OF THE PROXIMAL MARKER BAND BEING PLACED IN THE WORKING SURFACE OF THE BALLOON AND NOT DENOTING THE END OF THE WORKING SURFACE. TO PREVENT THIS PROBLEM, A NEW METHOD HAS BEEN PUT IN PLACE TO ALLOW FOR THE TOLERANCE IN THE BALLOON LENGTH, ENSURING ALL MARKER BANDS ARE PLACED CENTRALLY AND DENOTING THE WORKING SURFACE. THE RISK ANALYSIS FOR THIS PRODUCT HAS BEEN REVIEWED AND THE IMPACT TO THE PATIENT WAS DEEMED TO BE SMALL. THIS ISSUE MAINLY IMPACTS THE PHYSICIANS UNDERSTANDING OF THE WORKING SURFACE LENGTH OF THE BALLOON.

    Description of Event or Problem · 1

    DISTAL MARKER BAND PLACED INCORRECTLY DURING MANUFACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY LONG PTA CATHETER LIT CLEAR STREAM 5.0X220 5000 901

    Patients

    Seq Age Sex Outcome Treatment
    1