BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEK

    MDR report key: 2253455 · Received August 16, 2011

    Report

    Report Number
    9616666-2011-00009
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR PRODUCT DISTRIBUTORS HAVE REPORTED A COMPLAINTS TO US WITH THE FOLLOWING DESCRIPTION: PTA CATHETER SEPARATED AT BALLOON AND HYPOTUBE BROKE. THERE HAD TO BE SURGERY TO REMOVE THE PRODUCT. UPON RECEIPT OF THE COMPLAINT PRODUCT, THE UNIT WILL BE EXAMINED.

    Description of Event or Problem · 1

    PTA CATHETER SEPARATED AT BALLOON AND HYPOTUBE BROKE. THERE HAD TO BE SURGERY TO REMOVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50016811

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention