BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 3063631 · Received April 17, 2013

    Report

    Report Number
    9616099-2013-00231
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL PORTION OF THE SEPARATED SHAFT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE RIGHT SFA LESION WAS RE-CROSSED WITH THE GUIDEWIRE AND DILATATION WAS ATTEMPTED WITH A 4 X 100 MM POWERFLEX PRO BALLOON, BUT THE BALLOON RUPTURED AT 14 ATM. THE POWERFLEX PRO WAS REMOVED FROM THE PATIENT AND THE LESION WAS DILATED WITH 4 X 80 MM SLEEK BALLOON. A 6 X 80 MM SMART CONTROL STENT WAS PLACED AND THE LESION WAS POST-DILATED WITH 5 X 40 MM AVIATOR. FINALLY, LESION IN THE LEFT EIA WAS TREATED WITH 9 X 40 MM SMART CONTROL AND POST-DILATED WITH 7 X 40 MM POWERFLEX. THERE WAS NO REPORTED PATIENT INJURY. CONCOMITANT DEVICES: 7 X 40 MM POWERFLEX P3, CHEVALIER, FMD, 6 X 80 MM SMART CONTROL, TEMPO CATHETER, 5 X 40 MM AVIATOR, SLEEK 3.0MM X 80MM THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2013-20003 AND 9616099-2013-00231.

    Additional Manufacturer Narrative · 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. A SLEEK BALLOON WAS ADVANCED TO THE RIGHT SUPERFICIAL FEMORAL ARTERY BUT FAILED TO CROSS THE LESION. WHEN THE SLEEK WAS BEING REMOVED, IT BECAME CAUGHT ON THE SMART CONTROL STENT IN THE RIGHT EXTERNAL ILIAC ARTERY AND THE SHAFT OF THE SLEEK WAS SEPARATED AT THE EXIT PORT OF THE GUIDEWIRE PORT 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. THE DISTAL PORTION OF THE SEPARATED SHAFT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE RIGHT SUPERFICIAL FEMORAL ARTERY LESION WAS RE-CROSSED WITH THE GUIDEWIRE AND DILATATION WAS ATTEMPTED WITH A POWERFLEX PRO BALLOON, BUT THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE POWERFLEX PRO WAS REMOVED FROM THE PATIENT AND THE LESION WAS DILATED WITH A SLEEK BALLOON. A SMART CONTROL STENT WAS PLACED AND THE LESION WAS POST-DILATED WITH AN AVIATOR BALLOON CATHETER. TREATMENT OF THE LESION IN THE LEFT EXTERNAL ILIAC ARTERY WAS FINALLY CONDUCTED AND SUCCESSFULLY TREATED WITH A SMART CONTROL STENT AND POST-DILATED WITH A POWERFLEX. BOTH DEVICES PREPPED NORMALLY AND NO ANOMALIES WERE NOTED PRIOR TO USE. THE TYPE OF INFLATION DEVICE AND CONTRAST USED IS UNKNOWN; HOWEVER THE CONTRAST TO SALINE RATIO USED WAS 1:1. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED ¿BALLOON ¿ BURST AT/BELOW RBP¿ OF THE POWERFLEX PRO COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE, THERE ARE VESSEL CHARACTERISTICS (HEAVILY CALCIFIED, TORTUOUS WITH CHRONIC TOTAL OCCLUSION) THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE EVENT REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #1016427-2013-20003 AND 9616099-2013-00231.

    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 THE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166116 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS LIT CORDIS DE MEXICO NA 15703651

    Patients

    Seq Age Sex Outcome Treatment
    1