BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2033258 · Received March 30, 2011

    Report

    Report Number
    1058196-2011-00127
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. REVIEW OF LOT 15201876 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. COIL ASSEMBLY LOT # 15161508 WAS REVIEWED. IT WAS OBSERVED DURING REVIEW OF THIS LOT NO NON-CONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE NON-CONFORMANCES. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN ANEURYSM COIL EMBOLIZATION THE ORBIT MINI COMPLEX FILL COIL HAD RESISTANCE/FRICTION DURING ADVANCEMENT IN THE SL10 (BOSTON SCIENTIFIC) MICROCATHETER AND AFTER ADDITIONAL FORCE WAS USED TO ADVANCE THE DEVICE THE COIL UNRAVELED/STRETCHED WHEN RE-POSITIONING IN THE ANEURYSM. THE DEVICE WAS REMOVED WITH THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCT WITH NO REPORT OF PATIENT INJURY. THE TARGET SITE WAS AN ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. THE ANEURYSM SIZE/CHARACTERISTICS ARE NOT KNOWN. THE MICROCATHETER WAS NOT RE-SHAPED PRIOR TO USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED AT ALL TIMES. THERE WERE NO DAMAGES NOTED ON THE DEVICE AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER AND THE Y-CONNECTOR LOCKED TO SECURE IT. NO BALLOON OR STENT REMODELING PRODUCT WAS USED DURING THE PROCEDURE. RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER MID SHAFT, BUT THERE WAS NO KINK IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, AFTER THE RESISTANCE WAS MET, ADDITIONAL FORCE WAS UTILIZED TO ADVANCE THE COIL/DELIVERY SYSTEM, AND THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. DURING REPOSITIONING, THE COIL WAS LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. 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 15201876 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF PLASTIC BAG ON (B)(4) 2011. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS FOUND PARTIALLY UNZIPPED AND RESIDUES OF DRY BLOOD COULD BE OBSERVED INSIDE OF IT. PART OF THE SUPPORT COIL WAS FOUND OUTSIDE OF THE INTRODUCER THE REST OF IT, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE EMBOLIC COIL AND GRIPPER WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE SUPPORT COIL WAS RE-CAPTURED INSIDE OF THE INTRODUCER; AFTER THAT THE RECEIVED TRUFILL DCS ORBIT WAS INSERTED INTO A LAB SAMPLE PROWLER SELECT PLUS MICROCATHETER, WHICH WAS PREVIOUSLY FLUSHED. EVEN WITH THE DAMAGES PRESENT ON THE DEVICE IT WAS ABLE TO BE INTRODUCED OUT THE DISTAL END OF THE MICROCATHETER. RESISTANCE/FRICTION WITH A LAB SAMPLE MICROCATHETER WAS NOT CONFIRMED WITH FUNCTIONAL TESTING. IT APPEARS THAT PROCEDURAL FACTORS, POSSIBLY VESSEL CHARACTERISTICS AND THE CONCOMITANT MICROCATHETER CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED UNRAVELED/STRETCHING OF THE COIL WAS CONFIRMED WITH ANALYSIS. THE CAUSE OF THE KINKS FOUND ON THE HYPOTUBE AND THE STRETCHED COIL COULD NOT BE CONCLUSIVELY DETERMINED WITH ANALYSIS OF THE RETURNED DEVICE; HOWEVER, WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES LEAVING FROM THE FACILITY. THE INSTRUCTIONS FOR USE CAUTIONS TO NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF THE RESISTANCE UNDER FLUOROSCOPY. THESE MANIPULATIONS OF THE DELIVERY TUBE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. IF UNUSUAL FRICTION IS NOTED WITHIN THE INFUSION CATHETER, REMOVE THE DETACHABLE COIL UNIT. ADDITIONALLY THE IFU CAUTIONS THAT REPOSITIONING THE INFUSION CATHETER WHILE THE COIL IS DEPLOYED MAY LEAD TO DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. BASED ON THE AVAILABLE INFORMATION AND THE ANALYSIS IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY RELATED MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN ANEURYSM COIL EMBOLIZATION THE ORBIT MINI COMPLEX FILL COIL HAD RESISTANCE/FRICTION DURING ADVANCEMENT AND AFTER MANIPULATION BECAME UNRAVELED/STRETCHED. THE TARGET SITE WAS THE ACOM. NO FURTHER INFORMATION WAS AVAILABLE. RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER MID SHAFT, BUT THERE WAS NO KINK IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, AFTER THE RESISTANCE WAS MET, ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM, AND THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. DURING REPOSITIONING, THE COIL WAS LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. DURING THE PROCEDURE, THE COIL STRETCHED DURING REPOSITIONING IN THE ANEURYSM. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. MC WAS NOT RE-SHAPED PRIOR TO USE. NO BALLOON OR STENT REMODELING PRODUCT WAS USED DURING THE PROCEDURE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCT. MEDICATIONS GIVEN CONSISTED OF PRE-PROCEDURE ASPIRIN 150, PLAVIX 75, AND DURING THE PROCEDURE HEPARIN 1000 UNITS PER HOUR TOTAL 4000UNITS. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. 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. REVIEW OF LOT 15201876 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. (B)(4), THE INVESTIGATION WAS PERFORMED AN IT WAS CONCLUDES THAT THE PROCESS HAS THE CONTROLS NECESSARY FOR THE TIMELY DETECTION OF THIS TYPE OF DEFECTS FOR THIS REASON THE PRODUCT WAS NOT IMPACTED. (B)(4). COIL ASSY LOT # 15161508 WAS REVIEWED. IT WAS OBSERVED DURING REVIEW OF THIS LOT NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE NONCONFORMANCES. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST AS PER 637FM005 REV 2 AND 637FM007 REV 7. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. HOWEVER, THERE ARE POSSIBLE PROCEDURAL FACTORS, SPECIFICALLY ANY DIFFICULTY ANATOMY AND REPOSITIONING OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE COIL STRETCHED DURING REPOSITIONING IN THE ANEURYSM. RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER MID SHAFT, BUT THERE WAS NO KINK IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, AFTER THE RESISTANCE WAS MET, ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM, AND THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. DURING REPOSITIONING, THE COIL WAS LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. MC WAS NOT RE-SHAPED PRIOR TO USE. NO BALLOON OR STENT REMODELING PRODUCT WAS USED DURING THE PROCEDURE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCT. MEDICATIONS GIVEN CONSISTED OF PRE-PROCEDURE ASPIRIN 150, PLAVIX 75, AND DURING THE PROCEDURE HEPARIN 1000 UNITS PER HOUR TOTAL 4000UNITS. THE TARGET SITE WAS THE ACOM. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15201876

    Patients

    Seq Age Sex Outcome Treatment
    1 SL 10 MICROCATHETER.