BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2033565 · Received March 30, 2011

    Report

    Report Number
    1058196-2011-00129
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 15223479 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 9 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. COIL ASSEMBLY LOT # 15216572 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. 1 UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNIT WAS 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR LEFT (ITA) INTERNAL THORACIC ARTERY, WHEN THE ORBIT MINI COMPLEX FILL 3.5X9 COIL ((B)(4)) WAS ADVANCED THROUGH THE (MC) MICROCATHETER (RENEGADE, BOSTON SCIENTIFIC) LARGE FRICTION WAS NOTED BETWEEN THE COIL AND MC. WHEN PULLED BACK, THE COIL WAS NOTED UNRAVELED. ALL THE SYSTEMS, COILS DELIVERY SYSTEM AND MC WERE REMOVED AS A UNIT FROM THE PATIENT SUCCESSFULLY AND REPLACED TO OTHER NEW PRODUCT. NO ADDITIONAL TORQUE OR MANIPULATION WAS UTILIZED DURING THE TIME THE COIL WAS BEING DELIVER OR REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE COIL STRETCHED DURING THE INITIAL INSERTION. DURING INSERTION, THE Y CONNECTOR OR TOUHY WAS CLOSED ON THE COIL CAUSING THE EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. THE MC WAS NOT DAMAGE, AND NO DAMAGES WERE NOTICED ON THE MC, DELIVERY SYSTEM OR COIL THAT MAY HAVE CONTRIBUTED TO THE EVENT. ONCE THE DEVICES WERE REMOVED FROM THE PATIENT, THE COIL REMAINED ATTACHED ON THE DELIVERY SYSTEM, AND OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL ETC). NO FURTHER INFORMATION WAS AVAILABLE. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. SEVERAL KINKS WERE NOTED ON THE HYPOTUBE. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED AT THE PROXIMAL SIDE AND PRESENTED WITH KINKS AT THE DISTAL SIDE. INTRODUCER WAS UNZIPPED. GRIPPER AND SUPPORT COIL PRESENTED NO DAMAGES. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED NO DAMAGES; THE EMBOLIC COIL WAS KINKED AND STRETCHED. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. 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 15223479 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAIN. THE REPORTED RESISTANCE DURING INSERTION OF THE ORBIT SYSTEM COULD NOT BE EVALUATED WITH FUNCTIONAL TESTING DUE TO THE RECEIVED CONDITION OF THE DEVICE. IT CANNOT BE DETERMINED IF THE KINKS IN THE HYPOTUBE OCCURRED DURING PROCEDURAL USE OR POST USE. IF THE KINKS WERE RELATED TO PROCEDURAL USE, IT IS POSSIBLE THAT THIS CONTRIBUTED TO THE RESISTANCE. THE REPORTED STRETCHING OF THE COIL WAS CONFIRMED. THE CAUSE CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE ANALYSIS, INCLUDING DIMENSIONAL VERIFICATION, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS AND INTERACTION WITH THE CONCOMITANT MICROCATHETER MAY HAVE CONTRIBUTED; HOWEVER, NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC. SEVERAL KINKS WERE NOTED IN THE HYPOTUBE. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED AT PROXIMAL SIDE AND PRESENTED KINKS AT DISTAL SIDE. INTRODUCER WAS UNZIPPED. GRIPPER AND SUPPORT COIL PRESENTED NO DAMAGES. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED NO DAMAGES WHILE THE EMBOLIC COIL WAS KINKED AND STRETCHED. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. THE OUTER DIAMETER (OD) FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. 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 15223479 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAIN. THE REPORTED FAILURE BY THE CUSTOMER AS "RESISTANCE/FRICTION-DURING ADVANCEMENT" COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT (COIL STRETCHED); HOWEVER THE SEVERAL KINKS NOTED IN THE DEVICE COULD BE CONTRIBUTED TO THE FAILURE EXPERIENCED BY THE CUSTOMER. SECOND REPORTED FAILURE AS "UNRAVELED/STRETCHED-IN MICRO CATHETER" WAS CONFIRMED. THE CAUSE OF THE DAMAGES NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER DO NOT APPEAR TO BE MANUFACTURING RELATED DUE TO THE STRETCHED CONDITION APPEARS TO OCCUR AT THE TIME THAT THE DEVICE WAS RET REVIEW AND KINKS NOTED APPEAR TO OCCURRED DURING THE HANDLING OF THE UNIT DUE TO NO DAMAGES WERE REPORTED AFTER THE UNIT WAS REMOVED FROM THE PACKAGE. ADDITIONAL INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL FACTORS APPEAR TO BE CONTRIBUTED TO THESE FAILURES; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR LEFT (ITA) INTERNAL THORACIC ARTERY, WHEN THE ORBIT MINI COMPLEX FILL 3.5X9 COIL (637MF3509) WAS ADVANCED THROUGH THE (MC) MICROCATHETER (RENEGADE, BOSTON SCIENTIFIC) LARGE FRICTION WAS NOTED BETWEEN THE COIL AND MC. WHEN PULLED BACK, THE COIL WAS NOTED UNRAVELED. ALL THE SYSTEMS, COILS DELIVERY SYSTEM AND MC WERE REMOVED AS A UNIT FROM THE PATIENT SUCCESSFULLY AND REPLACED TO OTHER NEW PRODUCT. NO ADDITIONAL TORQUE OR MANIPULATION WAS UTILIZED DURING THE TIME THE COIL WAS BEING DELIVER OR REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE COIL STRETCHED DURING THE INITIAL INSERTION. DURING INSERTION, THE Y CONNECTOR OR TUOHY WAS CLOSED ON THE COIL CAUSING THE EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. THE MC WAS NOT DAMAGE, AND NO DAMAGES WERE NOTICED ON THE MC, DELIVERY SYSTEM OR COIL THAT MAY HAVE CONTRIBUTED TO THE EVENT. ONCE THE DEVICES WERE REMOVED FROM THE PATIENT, THE COIL REMAINED ATTACHED ON THE DELIVERY SYSTEM, AND OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL ETC). THE ADMITTING DIAGNOSIS WAS MAPCA. 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 15223479

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR RENEGADE MICROCATHETER