BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY LONG

    MDR report key: 1241799 · Received November 18, 2008

    Report

    Report Number
    9616666-2008-00004
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    November 14, 2008
    Manufacturer
    CLEAR STREAM
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DISTAL SECTION OF THE CATHETER WAS DETACHED AND NOT RETURNED. THE BALLOON RETAINED A STRONG IMPRESSION OF THE FOLD, WHICH SUGGESTS THAT IT WAS NOT FULLY EXPANDED. THE INNER APPEARED STRETCHED, SUGGESTING THAT SOME FORCE WAS APPLIED TO REMOVE THE CATHETER. WHILE IT IS NOT POSSIBLE TO DETERMINE DEFINITIVELY WHY THE PRODUCT FAILED IN THIS MANNER, IT WOULD APPEAR THAT THE LESION WAS PARTICULARLY DIFFICULT AND THAT THE BALLOON APPEARS TO HAVE BEEN CAUGHT ON SOMETHING, POSSIBLY A STENT, WHICH CAUSED IT TO TEAR ON REMOVAL OF THE PRODUCT. IF ALSO APPEARS THAT A LARGE FORCE APPLIED TO THE CATHETER TO REMOVE IT, WHICH MAY HAVE CONTRIBUTED TO THE BALLOON TEARING. THE MANUFACTURING DOCUMENTATION FOR THIS LOT WAS REVIEWED AND NO ANOMALIES WERE RECORDED. A SEARCH OF PREVIOUS COMPLAINTS AND PRODUCT TESTING DO NOT SHOW ANY INSTANCES OF THIS BALLOON FAILING IN THIS MANNER. THE RISK ANALYSIS FOR PRODUCTS WITH THIS BALLOON HAS ALSO BEEN REVIEWED AND SUFFICIENT CONTROLS ARE IN PLACE. THIS FAILURE MODE WILL BE FED INTO CLEARSTREAM'S POST MARKET SURVEILLANCE PROCEDURE AND FURTHER ANALYSIS WILL BE CARRIED OUT IF A SIMILAR COMPLAINT OF FAILURE IS ENCOUNTERED.

    Description of Event or Problem · 1

    (B) (4). BALLOON RUPTURED AT 14 ATMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY LONG PTA CATHETER LIT CLEAR STREAM 50003162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA