BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK

    MDR report key: 3904181 · Received May 26, 2014

    Report

    Report Number
    9616666-2014-00004
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CLEARSTREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RECEIPT IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PART OF THE BALLOON BECAME DETACHED FROM THE DEVICE. REPORTEDLY THE BALLOON GOT HUNG ON THE GUIDEWIRE. WHEN THE SURGEON ATTEMPTED TO REMOVE IT PART OF THE BALLOON STAYED IN THE PATIENT. THE REMAINDER OF THE BALLOON WHICH WAS LEFT IN THE PATIENT WAS SUCCESSFULLY REMOVED ON (B)(6) 2014. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310058 SLEEK LIT CLEARSTREAM TECHNOLOGIES, LTD. 50050428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention