BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 2830228 · Received November 13, 2012

    Report

    Report Number
    9616099-2012-00663
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR): ((B)(4) 2012) 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. REVIEW OF LOT 15170288 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE 3RD INFLATION OF THE BALLOON IN A PTA OF A LEFT BRACHIAL CEPHALIC VEIN, IN WHICH EACH INFLATION WAS BROUGHT TO 10ATMS, THE POWERFLEX P3 RUPTURED. THIS WAS CONFIRMED BY BACKFLOW OF BLOOD INTO THE INFLATION DEVICE AND IMMEDIATE LOSS OF PRESSURE OF 10 ATMS TO ZERO. AS THE STAFF ATTEMPTED TO WITHDRAW THE BALLOON OVER THE WIRE THE BALLOON SEIZED UP ON THE WIRE AND THEY SUBSEQUENTLY HAD TO REMOVE THE BALLOON AND THE WIRE AND SHEATH TOGETHER. AS THE STAFF ATTEMPTED TO BRING THE WIRE AND THE BALLOON BACK INTO THE SHEATH THE BALLOON WOULD NOT COME BACK INTO THE SHEATH. THE BALLOON MATERIAL THEN SHEARED OFF OF THE SHAFT OF THE BALLOON. AS A RESULT THE BALLOON, WIRE AND SHEATH HAD TO BE TAKEN OUT TOGETHER. THE VEIN WALL AT THE PUNCTURE SITE WAS NORMAL AND THE LESION THAT WAS BEING BALLOONED WAS A RESTENOSIS OF AN OLD STENT WITH STENOSIS 90%. AS THE STAFF PULLED THE BALLOON OUT OF THE BODY THE RADIOPAQUE TIP CAME OFF OF THE SHAFT AND BECAME LODGED IN THE SOFT TISSUE OF THE ACCESS SITE. IT HAD TO BE MANUALLY DUG OUT, USING A PAIR OF HEMOSTATS, AND PART OF THE BALLOON MATERIAL WAS ALSO LOST INTO THE SHEATH, WHICH WAS RETRIEVED AS WELL. THE BALLOON WAS BEING USED OVER A ROSEN WIRE. THERE WAS NO RESISTANCE FRICTION BETWEEN THE BALLOON AND THE WIRE. THE FEMORAL SHEATH WAS A 7FRENCH SHEATH. THERE WAS NO INJURY TO THE PATIENT REPORTED. ONE NON STERILE CATHETER POWERFLEX P3 F5 10X4 110CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. ONLY THE PROXIMAL SECTION OF THE BALLOON WAS RECEIVED. LEAK TEST REQUIRED PER DP 12169733 REV 1 COULD NOT BE PERFORMED DUE TO THE BALLOON CONDITIONS. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASION. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE INTERNAL SHAFT SEPARATION SURFACE SHOWED EVIDENCE OF ELONGATIONS. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE MARKER BANDS WERE NOT RECEIVED 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 FAILURES REPORTED BY THE CUSTOMER WERE CONFIRMED; HOWEVER THE EXACT CAUSE OF THE FAILURES COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. REFER TO MANUFACTURING WORK RO210035 REV 85, 11749551 REV12. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. THE COMPLAINTS OF BALLOON RUPTURE AND SEPARATION WERE CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURES COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENTS.

    Description of Event or Problem · 1

    DURING THE 3RD INFLATION OF THE BALLOON IN A PTA OF A LEFT BRACHIAL CEPHALIC VEIN, IN WHICH EACH INFLATION WAS BROUGHT TO 10 ATMS, THE POWERFLEX P3 RUPTURED. THIS WAS CONFIRMED BY BACKFLOW OF BLOOD INTO THE INFLATION DEVICE AND IMMEDIATE LOSS OF PRESSURE OF 10 ATMS TO ZERO. AS THE STAFF ATTEMPTED TO WITHDRAW THE BALLOON OVER THE WIRE THE BALLOON SEIZED UP ON THE WIRE AND THEY SUBSEQUENTLY HAD TO REMOVE THE BALLOON AND THE WIRE AND SHEATH TOGETHER. AS THE STAFF ATTEMPTED TO BRING THE WIRE AND THE BALLOON BACK INTO THE SHEATH THE BALLOON WOULD NOT COME BACK INTO THE SHEATH. THE BALLOON MATERIAL THEN SHEARED OFF OF THE SHAFT OF THE BALLOON. AS A RESULT THE BALLOON, WIRE AND SHEATH HAD TO BE TAKEN OUT TOGETHER. THE VEIN WALL AT THE PUNCTURE SITE WAS NORMAL AND THE LESION THAT WAS BEING BALLOONED WAS A RESTENOSIS OF AN OLD STENT WITH STENOSIS 90%. AS THE STAFF PULLED THE BALLOON OUT OF THE BODY THE RADIOPAQUE TIP CAME OFF OF THE SHAFT AND BECAME LODGED IN THE SOFT TISSUE OF THE ACCESS SITE. IT HAD TO BE MANUALLY DUG OUT, USING A PAIR OF HEMOSTATS, AND PART OF THE BALLOON MATERIAL WAS ALSO LOST INTO THE SHEATH, WHICH WAS RETRIEVED AS WELL. THE BALLOON WAS BEING USED OVER A ROSEN WIRE. THERE WAS NO RESISTANCE FRICTION BETWEEN THE BALLOON AND THE WIRE. THE FEMORAL SHEATH WAS A 7FRENCH SHEATH. THERE WAS NO INJURY TO THE PATIENT REPORTED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15170288

    Patients

    Seq Age Sex Outcome Treatment
    1