BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK RX PTA DILATION CATHETER

    MDR report key: 2599154 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00011
    Event Type
    Malfunction
    Date Received
    May 28, 2012
    Date of Event
    February 21, 2011
    Report Date
    February 23, 2011
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT HISTORY RECORD WAS 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 DURING INSERTION INTO SUBOCCLUSION THE CATHETER KINKED, THE OPERATOR STRAIGHTENED THE KINK AND THE SHAFT FRACTURED. THE PRODUCT WAS REMOVED AND THERE WAS NO PT INJURY RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK RX PTA DILATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50026231

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR