BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK RX PTA DILATATION CATHETER

    MDR report key: 2599034 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00012
    Event Type
    Injury
    Date Received
    May 28, 2012
    Date of Event
    May 26, 2011
    Report Date
    May 30, 2011
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVAL. THE CATHETER WAS RETURNED IN TWO PIECES. THE SHAFT WAS BROKEN APPROX 81MM FROM THE BODY BOND. THERE WERE EVIDENCE OF SEVERE KINKING DISTAL TO THE POINT OF BREAKAGE. THE OUTER TRANSITION HAD BEEN STRETCHED AND PULLED. THE BALLOON WAS INTACT AND WAS INFLATED WITH NO LEAK IN THE BALLOON AREA DETECTED. 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 IF RESISTANCE IS MET AND/OR THE USE OF A LONG SHEATH. THE IFU STATES: DO NOT ADVANCE THE GUIDEWIRE, BALLOON DILATATION CATHETER, OR ANY COMPONENT IF RESISTANCE IS MET WITHOUT FIRST DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION. 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 PRODUCT FAILED TO CROSS THE LESION, THE PHYSICIAN THEN MADE SEVERAL ATTEMPTS TO PUSH AND PULL THE PRODUCT BUT THERE WAS NO CHANGE. A PROXIMAL LESION WAS THEN DILATED WITH THE PRODUCT. DURING REMOVAL DIFFICULTY WAS ENCOUNTERED AND THE SHAFT BROKE ABOUT 20CM FROM THE DISTAL END, SURGICAL OPERATION WAS CONDUCTED TO REMOVE THE DETACHED PORTION. MODERATE CALCIFICATION AND A RATE OF STENOSIS OF THE VESSEL WAS 90%. NO PT INJURY WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK RX PTA DILATATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50029707

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention