BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 940386 · Received November 7, 2007

    Report

    Report Number
    2134243-2007-00012
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    October 5, 2007
    Report Date
    November 6, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: ON OCTOBER 11, 2007, ACIST MEDICAL SYSTEMS, INC. RECEIVED NOTIFICATION OF AN INCIDENT REPORT FILED BY REPORTER IN ANOTHER COUNTRY ON OCTOBER 9, 2007 TO THE ITALIAN COMPETENT AUTHORITY. PROBLEM DESCRIPTION: ACIST'S INITIAL ANALYSIS INDICATED THAT UNDER HIGH-PRESSURE USE OF THE ACIST SYSTEM, THE CONTRAST PORT OF THE ACIST A2000 SYRINGE MAY FRACTURE DURING THE INJECTION. FURTHER INFORMATION WAS OBTAINED FROM THE FIELD. IT WAS DETERMINED THAT THE MAJORITY OF REPORTED FRACTURES OCCURRED WHILE USING A HIGH-FLOW RATE AND SMALL CATHETERS. HEALTH RISK ASSESSMENT: ACIST MEDICAL ADVISORY BOARD (MAB) REVIEWED REPORTS OF A FAILURE OF THE A2000 SYRINGE UPPER VALVE ON MAY 15, 2007. THE FOLLOWING FACTORS WERE TAKEN INTO CONSIDERATION DURING REVIEW BY THE MAB. THE DEVICE FAILURE WOULD BE OBVIOUS TO THE USER AND DOES NOT POSE A PATIENT RISK. EJECTION OF CONTRAST MEDIA IS MESSY AND THERE IS A CHANGE THAT PERSONNEL IN VERY CLOSE PROXIMITY TO THE DEVICE MIGHT BE SPRAYED WITH CONTRAST. TOPICAL CONTRAST EXPOSURE DOES NOT NORMALLY CONSTITUTE A HEALTH RISK. ALTHOUGH PERSONNEL SHOULD ALWAYS WEAR EYE PROTECTION, THERE IS A VERY SMALL CHANCE THAT THEY COULD HAVE CONJUNCTIVAL EXPOSURE. EYE EXPOSURE TO STANDARD CONTRAST MEDIA DOES NOT NORMALLY CARRY SIGNIFICANT RISK OTHER THAN IRRITATION. DUE TO THE ROUTINE EXPOSURE TO BLOOD AND BIOLOGICAL FLUIDS IN THE CATHETERIZATION LABORATORY ENVIRONMENT, EYE WASH STATIONS SHOULD BE AVAILABLE. INADVERTENT EYE OR MUCOUS MEMBRANE EXPOSURE TO CONTRAST IS PREVENTED BY THE USE OF STANDARD CATH LAB PERSONAL PROTECTIVE EQUIPMENT AGAINST BLOODBORNE PATHOGENS INCLUDING THE MATERIAL SAFETY DATA SHEET (MSDS) FOR THE CONTRAST. BASED ON THESE CONSIDERATIONS, MAB CONCLUSION WAS THAT THIS TYPE OF DEVICE FAILURE, WHILE NOT DESIRABLE, DOES NOT CONSTITUTE A SIGNIFICANT RISK TO HEALTH. BACKGROUND: A2000 SYRINGES WERE MOLDED BY ADVANCED MOLDING TECHNOLOGY (AMT) UNTIL AUGUST 2006. AMT PRODUCED MOLDED A2000 SYRINGES FROM SEPTEMBER 2004 THROUGH AUGUST 2006. THE NUMBER OF ALL COMPLAINTS (GLOBAL) FOR A2000 SYRINGE KITS MOLDED BY AMT DURING 2004-2006 IS 19. THIS FAILURE CORRESPONDS WITH A FAILURE RATE OF 0.003%. A NEW MOLD WAS PRODUCED AND THE MOLDING WAS DONE BY A NEW SUPPLIER. SUPPLIER PRODUCED MOLDED A2000 SYRINGES FROM AUGUST 2006 THROUGH DECEMBER 2006. THE NUMBER OF COMPLAINTS (GLOBAL) FOR A2000 SYRINGE KITS MOLDED BY PHILLIPS IS 10. THIS FAILURE CORRESPONDS WITH A FAILURE RATE OF 0.011%. IN NOVEMBER 2006, MOLDING OF THE A2000 SYRINGE WAS TRANSFERRED TO A NEW SUPPLIER. NEW SUPPLIER PRODUCED MOLDED A2000 SYRINGES FROM DECEMBER 5, 2006 THROUGH JUNE 26, 2007. ACIST RECEIVED 211 COMPLAINTS (GLOBAL) RELATED TO FRACTURE OF THE A2000 SYRINGE MOLDED BY NEW SUPPLIER. THIS FAILURE CORRESPONDS WITH A FAILURE RATE OF 0.071%. A2000 SYRINGE KITS WERE DISTRIBUTED WITHIN ANOTHER COUNTRY FROM SEPTEMBER 2004 - SEPTEMBER 2007. THE TOTAL NUMBER OF COMPLAINTS FROM CUSTOMERS FROM SEPTEMBER 2004 - SEPTEMBER 2007 IS 40. THIS FAILURE CORRESPONDS WITH A FAILURE RATE OF 0.026%. REVIEW OF THE COMPLAINTS OF CRACKING SYRINGES REVEALED THREE DISTINCT FACTS; NEARLY ALL THE SYRINGES WERE FRACTURING DURING PROCEDURES USING SMALL CATHETERS (3-5 FR), HIGH FLOW RATES (>10ML/SEC) AND SHORT RISE TIMES (<0.5 SEC), THESE SYRINGES WERE CRACKING IN THE THREAD AREA OF THE CONTRAST PORT, AND THE HIGHER FAILURE RATES OCCURRED IN THE EARLIEST LOTS PRODUCED. LATER LOTS FAILED AT RATES ROUGHLY EQUIVALENT TO THOSE OF PRIOR COMPONENT MANUFACTURERS. ON MAY 17, 2007, ACIST ISSUED A PRODUCT HOLD ON ASSEMBLY OF A2000 SYRINGE KITS AT THE NEW SUPPLIER. IN COLLABORATION WITH NEW SUPPLIER, ACIST AND THE MATERIAL SUPPLIER CONDUCTED EVALUATION OF THE MOLDING PROCESS, EVALUATION OF THE PRODUCT AND PROCESS VALIDATION, AND ANALYSIS OF THE SYRINGE MATERIAL COMPOSITION. SEVERAL IMPROVEMENTS WERE IMPLEMENTED TO STRENGTHEN THE SYRINGE. LOTS PRODUCED BY THE REVISED TOOL/PROCESS DEMONSTRATED IMPROVED TACTILE STRENGTH WITH HIGH-PRESSURE TESTING. PRODUCTION WAS ALLOWED TO RESUME. ROOT CAUSE: USING THE ANALYSIS OF THE FAILED A2000 SYRINGES, AS WELL AS POST-MARKET INFORMATION, AND FUNDAMENTAL ENGINEERING INSIGHTS, THE ROOT CAUSE OF THE FAILURE WAS DETERMINED TO BE INADEQUATE MOLDING PROCESS. PROCESS SETTINGS, IN PARTICULAR THE INJECTION PRESSURE, POST INJECTION PRESSURE, AND POST INJECTION TIME WAS CREATING MOLD FILL AND COOLING RATE VARIATION THAT RESULTED IN MELD LINES AND WEAKER MATERIAL STRUCTURE. WHILE THERE WAS SOME SUPPORTING EVIDENCE THAT RESIN MOISTURE CONTENT WAS OUTSIDE OF THE MANUFACTURER'S RECOMMENDATION, NO CONCLUSIVE EVIDENCE INDICATES THE MATERIAL IN THESE LOTS HAD UNACCEPTABLE MOISTURE CONTENT OR THAT IT WAS SUFFICIENT TO IMPACT MATERIAL STRENGTH. AND THE TESTING ASSOCIATED THE PROCESS CHANGES TO POST INJECTION PRESSURE AND TIME PROVIDES CONCLUSIVE EVIDENCE TO SUPPORT THE MOLDING FACTORS BEING THE ROOT CAUSE. CORRECTIVE ACTION: AS AN ADDITIONAL PART OF PRODUCT RELEASE, ACIST HAS IMPLEMENTED BURST TESTING OF A SAMPLE FROM EACH MANUFACTURING LOT PRODUCED. LOTS ARE NOT RELEASED FOR DISTRIBUTION IF SAMPLES FRACTURE IN THE CONTRAST PORT BELOW 1700 PS. ACIST AND NEW SUPPLIER ARE WORKING ON A NEW BURST TEST FIXTURE THAT ALLOWS TESTING OF THE SYRINGE WITHOUT HAVING TO BUILD THEM INTO FINISHED ASSEMBLIES. THIS IS BEING DEVELOPED IN PARALLEL WITH THE PHILLIPS TOOL UPDATES TO ALLOW EARLIER DETECTION OF POSSIBLE SYRINGE ISSUES. ACIST AND NEW SUPPLIER ARE WORKING TOGETHER ON ENHANCING THE OLD SUPPLIER TOOL TO FURTHER IMPROVE THE PRODUCT. THE CURRENT SCHEDULE HAS COMPLETION OF THESE UPDATES IN FEBRUARY 2008. IN PARALLEL WITH THE ABOVE ACTIVITIES, NYPRO AND ACIST ARE WORKING ON A NEW TOOL. THIS TOOL WILL EVENTUALLY BECOME THE PRODUCTION TOOL. THE CURRENT SCHEDULE HAS COMPLETION OF THE ACTIVITIES PLUS FIELD TESTING TO BE COMPLETED IN AUGUST 2008. IN THE INTERIM, ACIST IS ALSO UTILIZING THE PREVIOUS SUPPLIER AND TOOL TO PRODUCE SYRINGES UNTIL THE OPTIMIZATION EFFORT CAN BE COMPLETED ON THE OLD SUPPLIER TOOL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: WHILE USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, BREAKAGE OF THE CONNECTOR OF THE A2000 SYRINGE DURING AN INJECTION OF CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST MULTIPLE USE SYRINGE KIT DXT ACIST MEDICAL SYSTEMS, INC. A2000 0817H

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR