BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK RX PTA DILATION CATHETER

    MDR report key: 2599166 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00009
    Event Type
    Malfunction
    Date Received
    May 28, 2012
    Report Date
    February 17, 2010
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. THE SHAFT WAS BROKEN APPROXIMATELY 275MM FROM THE DISTAL TIP, THERE WERE ALSO KINKS CLOSE TO THE TRANSITION OUTER. THE DISTAL PORTION OF THE PRODUCT WAS STUCK IN THE SHEATH (WHICH WAS RETURNED WITH THE PRODUCT) 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 CAUTION TO BE TAKEN WHEN RESISTANCE IS MET. THE IFU STATES: DO NOT ADVANCE THE GUIDEWIRE, BALLOON DILATION CATHETER, OR ANY COMPONENT IF RESISTANCE IS MET WITHOUT FIRST DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT BECAME STUCK IN THE SHEATH AND THE SHAFT BROKE. 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. 5001136

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR