BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEK

    MDR report key: 2253454 · Received August 12, 2011

    Report

    Report Number
    9616666-2011-00008
    Event Type
    Other
    Date Received
    August 12, 2011
    Date of Event
    May 28, 2011
    Report Date
    August 12, 2012
    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

    THIS IS A REPORT IN RELATION TO (B)(4), A COMPLAINT CONCERNING A SLEEK PRODUCT. IT WAS REPORTED THAT 'PT WAS (B)(6) MALE. THE LESION WAS LOCATED AT BELOW THE KNEE AND IT WAS VERY CALCIFIED. WHEN HE TRIED TO USE SLEEK, HE COULDN'T CROSS THE LESION. HE TRIED SEVERAL TIMES BUT HE FAILED TO CROSS IT. THEREFORE, HE USED NANOCROSS BALLOON INSTEAD. PRODUCT WILL BE RETURNED.' THE COMPLAINT PRODUCT RETURNED WAS REVIEWED BY A MEMBER OF OUR PRODUCT DEVELOPMENT TEAM. THE FINDINGS ARE AS FOLLOWS: THE PRODUCT WAS SEVERELY KINKED ALONG THE HYPOTUBE. THE SHAFT WAS BROKEN INTO TWO. THE BREAK WAS VERY CLOSE TO THE HUB, WHICH INDICATES THAT IT COULD HAVE BEEN PROCEDURAL RELATED. HOWEVER A DEFINITIVE ROOT CAUSE OF THE DEFECT COULD NOT BE IDENTIFIED. AS THE BREAK WAS NOT MENTIONED ON THE COMPLAINT, ADDITIONAL INFO WAS REQUESTED. CORDIS DID NOT MANAGE TO RECEIVE ANY OTHER INFO FROM THE PHYSICIAN DESPITE SEVERAL ATTEMPTS. AS STATED IN THE COMPLAINT, THERE WAS HEAVY CALCIFICATION INVOLVED WHICH MAY ALSO HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE MFG DOCUMENTATION FOR LOT: (B)(4) WAS REVIEWED AND NO ANOMALIES WHICH MAY HAVE RESULTED IN THE REPORTED FAILURE MODE WERE DETECTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE EVENT AS 'PT WAS (B)(6) MALE. THE LESION WAS LOCATED AT BELOW THE KNEE AND IT WAS VERY CALCIFIED. WHEN HE TRIED TO USE SLEEK, HE COULDN'T CROSS THE LESION. HE TRIED SEVERAL TIMES BUT HE FAILED TO CROSS IT. THEREFORE, HE USED NANOCROSS BALLOON INSTEAD.' HOWEVER, WHEN THE PRODUCT WAS RETURNED TO THE MFR FOR ANALYSIS, IT WAS SEPARATED INTO TWO. THE DISTRIBUTOR DO NOT KNOW WHETHER THIS HAPPENED AS PART OF THE PROCEDURE OR WHETHER IT WAS TRANSPORT RELATED. UPON INQUIRING FROM THE HEALTH CARE FACILITY SEVERAL TIMES, THEY DID NOT GET ANY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK PTA LIT CLEAR STREAM TECHNOLOGIES, LTD. 50027328

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention