BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK RX PTA DILATION CATHETER

    MDR report key: 2599155 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00010
    Event Type
    Malfunction
    Date Received
    May 28, 2012
    Report Date
    November 30, 2010
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    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 EVALUATION. IT WAS RETURNED IN THREE PIECES. THE SHAFT WAS BROKEN APPROXIMATELY 200MM FROM THE HUB. THE BALLOON WAS STILL INTACT AT BOTH ENDS AND NO DAMAGE WAS EVIDENT TO THE BALLOON. 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 MOST DISTAL POSITION ON THE GUIDEWIRE A GUIDE CATHETER/SHEATH WHICH IS LONG ENOUGH TO COVER THE RAPID EXCHANGE PORT MUST BE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON SEPARATED FROM THE SHAFT DURING THE PROCEDURE. THE BALLOON REMAINED ON THE GUIDEWIRE AND AS SUCH THE COMPLETE UNIT WAS REMOVED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK RX PTA DILATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50012610

    Patients

    Seq Age Sex Outcome Treatment
    1