BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK

    MDR report key: 1241793 · Received November 18, 2008

    Report

    Report Number
    9616666-2008-00007
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    November 14, 2008
    Manufacturer
    CLEARSTREAM TECHNOLOGIES
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS RECEIVED BACK TO CLEARSTREAM AND WAS EXAMINED BY A PRODUCT DEVELOPMENT ENGINEER. THE BALLOON HAD RUPTURED AND THE FAILURE MODE APPEARED TO BE A PINHOLE. THE PINHOLE WAS LOCATED IN THE CENTER OF THE BALLOON AND NO OBVIOUS SIGNS OF DAMAGE WERE APPARENT ON THE BALLOON WHICH COULD HAVE CAUSED THIS FAILURE MODE. IT IS NOT POSSIBLE TO DEFINITIVELY PINPOINT THE ROOT CAUSE OF THIS FAILURE MODE; HOWEVER, A SEARCH OF OUR COMPLAINTS DATABASE INDICATES THAT WE HAVE NOT EXPERIENCED THIS ISSUE WITH SLEEK PRODUCTS IN THE PAST, OR WITH THE CLEARSTREAM LITEPAC PRODUCT. WE WILL MONITOR THIS ISSUE THROUGH OUR POST MARKET SURVEILLANCE PROCEDURE AND REOPEN THIS INVESTIGATION IF FURTHER SIMILAR COMPLAINTS ARE RECEIVED.

    Description of Event or Problem · 1

    (B) (4). A 4.0X150MM BALLOON BURST AT 14 ATM. NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK PTA CATHETER LIT CLEARSTREAM TECHNOLOGIES 425-4015X 50003136

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention