BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM

    MDR report key: 3013198 · Received March 20, 2013

    Report

    Report Number
    9616099-2013-00158
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K060877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT CONCLUSION TO INCLUDE PRODUCT ANALYSIS. AS REPORTED, THE OPERATOR OF A PALMAZ BLUE PERIPHERAL STENT DELIVERY SYSTEM NOTICED A LEAKAGE OF FLUSHING SOLUTION THROUGH THE WALL OF THE SHAFT. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON AND RELEASE THE STENT. THERE WAS NO REPORT OF PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. ONE NON STERILE CATHETER PALMAZ BLUE ON AVIATOR PLUS, 7 MM DIAMETER, 70 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. A RUPTURE WAS NOTED IN THE SHAFT. NO OTHER DAMAGES WERE NOTED. A LEAK TEST WAS NOT PERFORMED DUE TO THE DEVICE CONDITION. SEM RESULTS SHOWED THAT THE INFLATION LUMEN AND THE GUIDE WIRE LUMEN PRESENT BURST DAMAGE IN TWO EVENTS. ALSO AN UNZIPPED LIKE CONDITION CONNECTS THE TWO RUPTURES / BURST. THIS UNZIPPED CONDITION IS ALSO PRESENT IN THE SECTION OF THE GUIDE WIRE INSERTION AT GUIDE WIRE LUMEN. THERE IS NO TOOL OR CUTTING MARKS ALONG THE DAMAGE BUT A WIRE WAS LOCATED AT 25 CM FROM THE DISTAL SECTION AND IS POSSIBLE THAT THE WIRE INDUCED THE UNZIPPED CONDITION BUT IT CANNOT BE CONCLUDED WHAT COULD CAUSE THE RUPTURES / BURST AT INFLATION AND GUIDE WIRE LUMEN. 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 BODY/SHAFT/LEAKAGE REPORTED BY THE COSTUMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON BURST FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS LIMITED INFORMATION AVAILABLE AND ATTEMPTS TO GATHER CLARIFICATION HAVE BEEN UNSUCCESSFUL. BASED ON THE ANALYSIS AND THE PICTURES OF THE RETURNED DEVICE, THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN RELATED TO PROCEDURAL FACTORS AND INTERACTION BETWEEN THE GUIDEWIRE AND THE GUIDEWIRE LUMEN OF THE DEVICE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED LEAKAGE COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE OPERATOR OF A PALMAZ BLUE PERIPHERAL STENT DELIVERY SYSTEM NOTICED A LEAKAGE OF FLUSHING SOLUTION THROUGH THE WALL OF THE SHAFT. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON AND RELEASE THE STENT. THERE WAS NO REPORT OF PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. 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 PRODUCT WAS NOT RETURNED AND THE CUSTOMER COMPLAINT OF "BODY/SHAFT - LEAKAGE" COULD NOT BE CONFIRMED. WITHOUT RETURN OF THE DEVICE AND WITH THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION AS TO THE CAUSE OF THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE SHAFT LEAKAGE IS RELATED TO THE MANUFACTURING OF THE PRODUCT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, THE OPERATOR NOTICED A LEAKAGE OF FLUSHING SOLUTION THROUGH THE WALL OF THE SHAFT OF A PALMAZ BLUE PERIPHERAL STENT SYSTEM. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON AND RELEASE THE STENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116783 PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM ENDOVASCULAR SDS/STENTS FGE CORDIS DE MEXICO NA 15585489

    Patients

    Seq Age Sex Outcome Treatment
    1