BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK RX PTA DILATATION CATHETER

    MDR report key: 2599043 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00008
    Event Type
    Injury
    Date Received
    May 28, 2012
    Report Date
    February 10, 2010
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVAL. THE SHAFT WAS BROKEN APPROX 500MM FROM THE DISTAL TIP, THERE WERE ALSO KINKS ON THE SHAFT. THE LOT HISTORY RECORD WAS ALSO REVIEWED FOR THE PRODUCT, THE LOT MET ALL RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE USER DID NOT FOLLOW IFU INSTRUCTIONS REGARDING THE USE OF A LONG SHEATH. THE IFU STATES: WHEN THE SLEEK CATHETER IS IN IT'S POST DISTAL POSITION ON THE GUIDEWIRE A GUIDE CATHETER/SHEATH WHICH IS LONG ENOUGH TO COVER THE RAPID EXCHANGE PORT MUST BE USED. NOTE: THE DATE OF THIS REPORT WAS A YEAR AFTER THE EXPIRATION DATE OF THE PRODUCT AND NO EVENT DATE COULD BE OBTAINED BY THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT THROUGH THE SFA RESISTANCE WAS MET. IT WAS DECIDED TO REMOVE THE PRODUCT BUT DURING REMOVAL THE HYPOTUBE FRACTURED THE BALLOON PORTION REMAINED INSIDE THE PT. A SNARE WAS USED BUT FAILED TO RETRIEVE THE PRODUCT AS SUCH THE PT UNDERWENT SURGERY TO REMOVE THE PRODUCT. IT WAS SUBSEQUENTLY REPORTED THAT THE PT WAS DOING WELL AND HAD FULLY RECOVERED FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK RX PTA DILATATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50011518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention