BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK RX

    MDR report key: 4381160 · Received December 2, 2014

    Report

    Report Number
    9616666-2014-00013
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE PENDING RECEIPT OF THE DEVICE. THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE. THE TARGET LESION WAS AN UNKNOWN ENDO VESSEL. WHEN PUSHING THE DEVICE INTO THE SHEATH, THE SHAFT WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779211 SLEEK RX NONE LIT CLEAR STREAM TECHNOLOGIES, LTD. 50104035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention