BEUDAMED
    FDA Adverse Event Summary report: N

    SLEEK PTA DILATATION CATHETER

    MDR report key: 3063679 · Received April 17, 2013

    Report

    Report Number
    1016427-2013-20003
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED, THE SLEEK BALLOON CATHETER SEPARATED IN THE VESSEL AND WAS SNARED SUCCESSFULLY WITH THE SNARE CATHETER FROM THE PATIENT. THE BALLOON SEPARATED BECAUSE IT WAS PULLED WITH ITS GUIDEWIRE PORT CAUGHT ON THE DISTAL EDGE OF A STENT PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA). ALSO, A POWERFLEX PRO BALLOON RUPTURED AT 14 ATM IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS MALE (AGE UNKNOWN). THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS ALSO STENOSIS IN LEFT EIA AND RIGHT EIA. THERE WAS MILD CALCIFICATION AND HEAVY TORTUOSITY IN THE SFA AND THE RATE OF STENOSIS WAS 100%. APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY WITH A 6FR GUIDING SHEATH. THE GUIDING SHEATH WAS DELIVERED TO THE OSTIUM OF RIGHT COMMON ILIAC ARTERY (CIA) THROUGH THE STEEP AORTO-ILIAC BIFURCATION. FIRST, THE RIGHT EIA WAS PRE-DILATED WITH 6 X 40 MM POWERFLEX P3 BALLOON AND AN 8 X 80 MM SMART CONTROL STENT WAS PLACED. POST-DILATATION WAS CONDUCTED WITH 7 X 40 MM POWERFLEX P3 BALLOON. NEXT, TREATMENT OF RIGHT SFA WAS ATTEMPTED. THE RIGHT SFA WAS CROSSED WITH 0.014 INCH GUIDEWIRE (CHEVALIER, FMD) WITH THE BACK-UP OF A TEMPO CATHETER. A 3 X 80 MM SLEEK BALLOON WAS ADVANCED TO THE RIGHT SFA BUT FAILED TO CROSS THE LESION. WHEN THE SLEEK WAS BEING REMOVED, IT BECAME CAUGHT ON THE SMART IN THE RIGHT EIA AND THE SHAFT OF THE SLEEK WAS SEPARATED AT EXIT PORT OF GW WHEN THE PHYSICIAN TRIED TO WITHDRAW THE SLEEK AGAINST RESISTANCE. ONLY THE PROXIMAL PORTION OF THE SHAFT WAS REMOVED FROM THE PATIENT. IN ORDER TO REMOVE THE DISTAL PORTION OF THE SHAFT, AN ADDITIONAL STICK WAS MADE IN THE RIGHT FEMORAL ARTERY AND A JINDO GUIDEWIRE WAS INSERTED. THE JINDO WIRE WAS PULLED THROUGH FROM THE RIGHT FEMORAL TO THE LEFT FEMORAL AND A SNARE CATHETER WAS DELIVERED FROM THE LEFT FEMORAL ALONG THE JINDO WIRE.

    Description of Event or Problem · 1

    DURING A PTA/STENTING PROCEDURE, A SLEEK BALLOON FAILED TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. UPON REMOVAL OF THE BALLOON, THE SHAFT GOT CAUGHT ON THE PREVIOUSLY IMPLANTED STENT AND THE CATHETER SEPARATED IN THE VESSEL. THE SEPARATED PIECE WAS REMOVED WITH A SNARE WITHOUT DIFFICULTY. A POWERFLEX PRO BALLOON WAS THEN USED TO TREAT THE LESION BUT RUPTURED AT 14 ATMOSPHERES DURING PRE-DILATION OF THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER CORDIS BALLOON WAS USED SUCCESSFULLY TO PRE-DILATE THE LESION AND STENTING WAS CONDUCTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY WITH A 6FR SHEATH TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY (% STENOSIS UNKNOWN), A CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND A LESION IN THE LEFT EXTERNAL ILIAC ARTERY . THE SHEATH WAS DELIVERED TO THE OSTIUM OF THE RIGHT COMMON ILIAC ARTERY THROUGH THE STEEP AORTO-ILIAC BIFURCATION. THE LESION IN THE RIGHT EXTERNAL ILIAC ARTERY WAS PRE-DILATED WITH A POWERFLEX P3 BALLOON AND A SMART CONTROL STENT WAS SUCCESSFULLY PLACED. POST-DILATATION WAS CONDUCTED WITH THE POWERFLEX P3 BALLOON. NEXT, TREATMENT OF THE CTO IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS ATTEMPTED. THE VESSEL WAS DESCRIBED AS HEAVILY CALCIFIED AND TORTUOUS. THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS CROSSED WITH A 0.014 INCH GUIDEWIRE WITH THE BACK-UP OF A TEMPO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165393 SLEEK PTA DILATATION CATHETER PTA CATHETERS LIT CLEARSTREAM TECHNOLOGIES LTD NA 50043257

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R