BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLEEK RX PTA DILATION CATHETER

    MDR report key: 2602684 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00013
    Event Type
    Death
    Date Received
    May 28, 2012
    Date of Event
    January 25, 2011
    Report Date
    February 21, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. THE CATHETER WAS RETURNED IN THREE PIECES. THERE WAS A BREAK APPROXIMATELY 54CM FROM THE STRAIN RELIEF AND ANOTHER 99CM FROM THE STRAIN RELIEF, AN ADDITIONAL BREAK WAS OBSERVED APPROXIMATELY 50MM DISTAL TO THE SECOND PROXIMAL MARKER BAND. SIX KINKS IN THE SHAFT AND A CURVED BEND IN THE THIRD BROKEN SECTION WERE ALSO NOTED. THE LOT HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER; THE LOT MET ALL RELEASE CRITERIA. A COPY OF THE IFU AND PROCEDURAL IMAGES WERE PROVIDED AND REVIEWED BY AN ADVISING PHYSICIAN. ON REVIEW THE PHYSICIAN STATED: IN A CONTRA--LATERAL LOWER LIMB PROCEDURE SUCH AS IN THIS CASE, THE VECTOR FORCES WORK AGAINST THE OPERATOR AS THE BALLOON WILL HAVE TO TRAVEL THROUGH ALMOST 180 DEGREES. EVEN WITH THE USE OF A 0.035" GUIDEWIRE THERE IS A TENDENCY FOR THE CATHETER TO SPIKE UP INTO THE AORTA DURING FORWARD TRACKING. THIS TENDENCY IS INCREASED USING A LIGHTER 0.014" SYSTEM AND THIS RISK IS FURTHER INCREASED WITH THE USE OF A RAPID EXCHANGE CATHETER. THIS RISK HIGHLIGHTS THE NECESSITY TO PRE-PLACE A LONG INTRODUCER OR GUIDE CATHETER OVER THE BIFURCATION. THE PHYSICIAN WENT ON TO SAY HE SUSPECTED FROM REVIEW OF THE INFO PROVIDED, THAT THE MECHANISM THAT OPERATED IN THIS CASE WAS THAT THE SOFT OVER THE WIRE FLEXIBLE SEGMENT OF THE CATHETER TRACKED OVER THE BIFURCATION BUT THE TRANSITION SEGMENT DID NOT. THE BALLOON CATHETER KINKED FORMING A POINT. IN THE ABSENCE OF A LONG SHEATH/INTRODUCER THIS POINTED SEGMENT ACTED AS A PENETRATING INSTRUMENT. FRACTURE FOLLOWED AND PENETRATION OF THE AORTA OCCURRED AS A RESULT OF THE ATTEMPTED FORWARD TRACKING. PER THE CLINICAL EXPERT, THE MOST PROBABLE ROOT CAUSE OF THE CATHETER BREAK WAS FAILURE OF THE ATTENDING PHYSICIAN TO USE A SHEATH/GUIDE CATHETER OF SUITABLE LENGTH DURING THE PROCEDURE, AS DEFINED BY THE IFU. FURTHERMORE, SUBSEQUENT TO THE CATHETER BREAK NEAR THE UNPROTECTED (NON-SHEATHED) REGION OF THE BIFURCATION, FORWARD PUSHING FORCES LIKELY CONTRIBUTED TO THE REPORTED PENETRATION OF AORTA. THE IFU STATES: WHEN THE SLEEK CATHETER IS IN ITS 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 A CROSS OVER OF THE BIFURCATION THE CATHETER BROKE IN TWO. THE DISTAL PART WAS LOCATED APPROXIMATELY 10CM BELOW THE GROIN IN THE RIGHT LEG AND THE PROXIMAL PART WAS LOCATED INSIDE THE AORTA. A SNARE WAS INSERTED IN AN ATTEMPT TO REMOVE THE DISTAL PART OF THE CATHETER BUT WAS UNSUCCESSFUL. A LONGER GUIDEWIRE AND SHEATH WERE INSERTED AND THE SNARE RE-INTRODUCED BUT WAS STILL UNSUCCESSFUL. A CLOSURE DEVICE WAS USED AND THE PT WAS TRANSFERRED TO INTENSIVE CARE. AT 3PM THE PT WENT INTO SHOCK, INVESTIGATION REVEALED BLEEDING AND AFTER UNSUCCESSFUL ATTEMPTS TO STOP THE BLEEDING THE PT DIED. IT WAS OBSERVED THAT THE AORTA HAD BEEN PERFORATED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK RX PTA DILATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50016008

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death