BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1973932 · Received January 31, 2011

    Report

    Report Number
    9610978-2011-00022
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: CONTRAST: OPTIRAY BY MALLINKRODT, INDEFLATOR: ENCORE26 OR ARIA BY BOSTON SCIENTIFIC. ONE NON STERILE UNIT POWERFLEX P3 F5 12 X 4 AND 80 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RADIAL BURST, BOTH MARKER BANDS WERE NOTED IN CATHETER. THE BALLOON WAS SEPARATED IN TWO PARTS; ONE PART OF THE BALLOON WAS JOINED TO THE PROXIMAL SEAL AND THE OTHER TO THE DISTAL TIP. DRY BLOOD RESIDUES WERE NOTED IN THE BALLOON AND HUB. THE INNER BODY WAS CUT AND SEPARATED FROM DISTAL TIP END; PRESSING MARKS WERE NOTED AT 1 CM APPROXIMATELY FROM THE CUT IN THE INNER BODY. THE FUNCTIONAL TEST WAS NOT POSSIBLE TO BE PERFORMED SINCE BALLOON WAS RADIAL BURST AND THE INNER BODY WAS CUT. A SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT, RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF HEAVY WRINKLING AND MATERIAL SPLITS/ABRASIONS. THE INNER SURFACE OF THE BALLOON EXHIBITED NO EVIDENCE OF DAMAGE. THE INNER BODY WAS FOUND TO BE TORN APART AND PRESENTS IRREGULAR PATTERNS AND ELONGATIONS; THESE ARE CHARACTERISTICS OF PIECES THAT WERE SUBJECTED TO PULLING/STRETCHING UNTIL FAILURE. THE EXACT CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. 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. FAILURES MODES OF BURST-AT/BELOW RBP AND SEPARATED-IN PATIENT WERE CONFIRMED WITH THE EXCEPTION OF THE FAILURE MODE OF WITHDRAWAL DIFFICULTY - THROUGH GUIDE SHEATH BECAUSE OF THE CONDITION OF THE RECEIVED COMPLAINT UNIT; HOWEVER, THE EXACT CAUSE OF THE FAILURES COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. PRESSING MARKS NOTED DURING VISUAL ANALYSIS COULD BE RELATED TO THE USE OF THE DEVICE DURING PREPARATION OR MEDICAL PROCEDURE. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. REFER TO MANUFACTURING WORK (B)(4). ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9610978-2011-00022 AND 9616099-2011-00064.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE TO TREAT INSTENT RESTENOSIS OF AN UNKNOWN SMART CONTROL STENT, A POWERFLEX BALLOON RUPTURED DURING INFLATION, SEPARATED IN THE PATIENT AND HAD DIFFICULTY DURING WITHDRAWAL. THIS IS AN (B)(6) MALE WITH UNKNOWN MEDICAL HISTORY. IT WAS REPORTED THAT DURING ANGIOPLASTY OF A 70% RESTENOTIC SMART CONTROL STENT IN THE LEFT SUBCLAVIAN VEIN, ANGIOPLASTY WAS PERFORMED WITH A 12X4MM POWERFLEX BALLOON. THE TARGET AREA WAS A T JUNCTION OF A COVERED BARD STENT AND A SMART CONTROL STENT AT CEPHALIC VEIN-SUBCLAVIAN VEIN CONFLUENCE. THERE WAS NO CALCIFICATION OR VESSEL TORTUOUSITY. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT AND THE DEVICE PREPPED NORMALLY. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR DIFFICULTY CROSSING THE LESION. THE BALLOON INFLATED NORMALLY AND NO LEAKAGE WAS NOTED FROM THE BALLOON, SHAFT, HUB OR UNKNOWN SEGMENT. THE MAXIMUM INFLATION PRESSURE WAS LESS THAN OR EQUAL TO MAX BURST PRESSURE 8ATM. THE PHYSICIAN WAS NOT SURE OF PRESSURE IN THE BALLOON WHEN IT RUPTURED INSIDE THE STENT. WHEN BALLOON WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH: HOWEVER, IT GOT HUNG UP AT TIP OF THE SHEATH AND COULDN'T BE WITHDRAWN. AS THE PHYSICIAN TRIED TO PULL THE BALLOON THROUGH THE SHEATH, IT SHEARED OFF AT THE TIP OF THE SHEATH. THE PHYSICIAN PULLED OUT THE SHEATH AND RECOVERED THE ONE PIECE BALLOON FRAGMENT WITH A CUTDOWN AT THE INSERTION SITE. THE BALLOON PIECE WAS RECOVERED A FEW CENTIMETERS FROM THE SITE AND PATIENT WAS FINE. THE BALLOON AND FRAGMENT ARE BEING RETURNED FOR ANALYSIS. THE BRAND OF CONTRAST MEDIA USED WAS OPTIRAY AT A 50/50 RATIO WITH AN ENCORE26 OR ARIA INDEFLATOR BY BOSTON SCIENTIFIC. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. ONE NON STERILE UNIT POWERFLEX P3 F5 12 X 4 AND 80 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RADIAL BURST, BOTH MARKER BANDS WERE NOTED IN CATHETER. THE BALLOON WAS SEPARATED IN TWO PARTS; ONE PART OF THE BALLOON WAS JOINED TO THE PROXIMAL SEAL AND THE OTHER TO THE DISTAL TIP. DRY BLOOD RESIDUES WERE NOTED IN THE BALLOON AND HUB. THE INNER BODY WAS CUT AND SEPARATED FROM DISTAL TIP END; PRESSING MARKS WERE NOTED AT 1 CM APPROXIMATELY FROM THE CUT IN THE INNER BODY. THE FUNCTIONAL TEST WAS NOT POSSIBLE TO BE PERFORMED SINCE BALLOON WAS RADIAL BURST AND THE INNER BODY WAS CUT. A SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT; RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF HEAVY WRINKLING AND MATERIAL SPLITS/ABRASIONS. THE INNER SURFACE OF THE BALLOON EXHIBITED NO EVIDENCE OF DAMAGE. THE INNER BODY WAS FOUND TO BE TORN APART AND PRESENTS IRREGULAR PATTERNS AND ELONGATIONS; THESE ARE CHARACTERISTICS OF PIECES THAT WERE SUBJECTED TO PULLING/STRETCHING UNTIL FAILURE. THE EXACT CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. 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. FAILURES MODES OF BURST-AT/BELOW RBP AND SEPARATED-IN PATIENT WERE CONFIRMED WITH THE EXCEPTION OF THE FAILURE MODE OF WITHDRAWAL DIFFICULTY THROUGH GUIDE SHEATH BECAUSE OF THE CONDITION OF THE RECEIVED COMPLAINT UNIT; HOWEVER, THE EXACT CAUSE OF THE FAILURES COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. PRESSING MARKS NOTED DURING VISUAL ANALYSIS COULD BE RELATED TO THE USE OF THE DEVICE DURING PREPARATION OR MEDICAL PROCEDURE. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. (B)(4). ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINTS OF BALLOON RUPTURE AND SEPARATION WERE CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURES COULD NOT BE DETERMINED. THE CONDITION OF THE DEVICE DID NOT SUPPORT FUNCTIONAL ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENTS. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT TARGET VESSEL / LESION ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED BURST. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT AND TARGET VESSEL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED RESTENOSIS. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9610978-2011-00022 AND 9616099-2011-00064.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ANGIOPLASTY OF A 70% RESTENOTIC LESION IN THE LEFT SUBCLAVIAN VEIN, ANGIOPLASTY WAS PERFORMED WITH A 12X4MM POWERFLEX BALLOON (PRODUCT CODE- 420-2040S AND LOT NUMBER 15178919) WITHIN A PREVIOUSLY IMPLANTED UNKNOWN SMART CONTROL STENT (IMPLANTED ON AN UNKNOWN DATE) AND EXTENDING INTO A FLUENCY STENT GRAFT IN THE SUBCLAVIAN VEIN. THE PHYSICIAN WAS NOT SURE OF PRESSURE IN THE BALLOON WHEN IT RUPTURED INSIDE THE STENT. WHEN BALLOON WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH, IT GOT HUNG UP AT TIP OF THE SHEATH AND COULDN'T BE WITHDRAWN. AS THE PHYSICIAN TRIED TO PULL THE BALLOON THROUGH THE SHEATH, IT COULD HAVE SHEARED OFF AT THE TIP OF THE SHEATH. THE PHYSICIAN PULLED OUT THE SHEATH AND RECOVERED THE ONE PIECE BALLOON FRAGMENT BY A CUTDOWN AT THE INSERTION SITE. THE BALLOON PIECE WAS RECOVERED A FEW CENTIMETERS FROM THE SITE AND PATIENT WAS FINE. THE BALLOON AND FRAGMENT ARE BEING RETURNED FOR ANALYSIS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT AND THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST MEDIA USED WAS OPTIRAY BY MALLINKRODT AT A 50/50 RATIO WITH AN ENCORE26 OR ARIA INDEFLATOR BY BOSTON SCIENTIFIC. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR DIFFICULTY CROSSING THE LESION. A 75 DEGREE ANGLE WAS BALLOONED ACROSS A " T" JUNCTION OF COVERED BARD STENT AND SMART CONTROL STENT AT CEPHALIC VEIN-SUBCLAVIAN VEIN CONFLUENCE. THE BALLOON INFLATED NORMALLY BUT NO LEAKAGE WAS NOTED FORM THE BALLOON, SHAFT, HUB OR UNKNOWN SEGMENT. THE MAXIMUM INFLATION PRESSURE WAS LESS THAN OR EQUAL TO MAX BURST PRESSURE 8ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15178919

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R