BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2011504 · Received March 9, 2011

    Report

    Report Number
    1058196-2011-00094
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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 15092391 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. COIL ASSY LOT # 15086432 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. 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 WTIHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ORBIT MINI COMPLEX FILL 2.5X3.5 COIL WAS STRETCHED DURING THE INSERTION INTO THE ANEURYSM. DURING THE EVENT, THE COIL AND NON-CORDIS (MC) MICROCATHETER WERE REMOVED AS A UNIT FROM THE PATIENT. NO ADDITIONAL TORQUE OR MANIPULATION WAS UTILIZED DURING THE TIME THE COIL WAS BEING DELIVER OR REMOVED. AN EV3 HYPERFORM 4X7 BALLOON WAS USED DURING THE PROCEDURE. AFTER REMOVAL, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. DURING PLACEMENT OF THE COIL, NO RESISTANCE OCCURRED DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING, AND BEFORE STRETCHING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, NO RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED. ONCE THE DEVICES WERE REMOVED FROM THE PATIENT, THE COIL REMAINED ATTACHED ON THE DELIVERY SYSTEM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO DAMAGES WERE NOTICED ON THE MC, DELIVERY SYSTEM OR COIL THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL ETC), AND THE COIL DID NOT PREMATURELY DETACH ONCE IT WAS INSIDE THE MICROCATHETER. THE ANEURYSM WAS SACCULAR AND MEASURED 5.5X2.7X3.1, NECK 3.1, NECK TO SAC RATIO WAS 1:1.4. THE PROCEDURE WAS COMPLETED WITH THE SAME SIZE COIL. THERE WAS NO ADVERSE EVENT, AND NO FURTHER INFORMATION. THE DEVICE 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 15092391 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. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE REPORTED STRETCHED ORBIT COIL, BASED ON THE REPORT WIDE-NECK CHARACTERISTIC WITH USE OF BALLOON REMODELING, IT IS POSSIBLE THAT DEVICE INTERACTION WITH THE BALLOON CONTRIBUTED TO THE STRETCHING OF THE COIL DURING POSITIONING. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE ORBIT MINI COMPLEX FILL 2.5 X 3.5 COIL WAS STRETCHED DURING THE INSERTION INTO THE ANEURYSM. DURING THE EVENT, THE COIL AND NON-CORDIS (MC) MICROCATHETER WERE REMOVED AS A UNIT FROM THE PATIENT. NO ADDITIONAL TORQUE OR MANIPULATION WAS UTILIZED DURING THE TIME THE COIL WAS BEING DELIVER OR REMOVED. AN EV3 HYPERFORM 4X7 BALLOON WAS USED DURING THE PROCEDURE. AFTER REMOVAL, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. DURING PLACEMENT OF THE COIL, NO RESISTANCE OCCURRED DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING, AND BEFORE STRETCHING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, NO RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED. ONCE THE DEVICES WERE REMOVED FROM THE PATIENT, THE COIL REMAINED ATTACHED ON THE DELIVERY SYSTEM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO DAMAGES WERE NOTICED ON THE MC, DELIVERY SYSTEM OR COIL THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL ETC), AND THE COIL DID NOT PREMATURELY DETACH ONCE IT WAS INSIDE THE MICROCATHETER. THE ANEURYSM WAS SACCULAR AND MEASURED 5.5 X 2.7 X 3.1, NECK 3.1, NECK TO SAC RATIO WAS 1:1.4. THE PROCEDURE WAS COMPLETED WITH THE SAME SIZE COIL. THERE WAS NO ADVERSE EVENT, AND NO FURTHER INFORMATION. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL AND GRIPPER WERE INSPECTED AND NO DAMAGES WERE FOUND ON THEM. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS FOUND STRETCHED. THE EMBOLIC COIL AND THE GRIPPER WERE INSPECTED UNDER MICROSCOPE. THE EMBOLIC COIL WAS FOUND STRETCHED AND THE GRIPPER WAS NOT DAMAGED. 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 DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS. THE REPORTED STRETCHED COIL WAS CONFIRMED. THE CAUSE OF THE KINKS ON HYPOTUBE AND ALSO THE STRETCHED EMBOLIC COIL COULD NOT BE CONCLUSIVE DETERMINATE. AS REPORTED, THIS OCCURRED DURING PROCEDURAL USE; ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES FROM LEAVING THE FACILITY. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE REPORTED STRETCHED ORBIT COIL, BASED ON THE REPORT WIDE-NECK CHARACTERISTIC WITH USE OF BALLOON REMODELING, IT IS POSSIBLE THAT DEVICE INTERACTION WITH THE BALLOON CONTRIBUTED TO THE STRETCHING OF THE COIL DURING POSITIONING. WITH REVIEW OF THE DEVICE HISTORY RECORDS AND ANALYSIS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    NO DAMAGES WERE NOTICED ON THE MC, DELIVERY SYSTEM OR COIL THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL ETC), AND THE COIL DID NOT PREMATURELY DETACH ONCE IT WAS INSIDE THE MICROCATHETER. THE ANEURYSM WAS SACCULAR AND MEASURED 5.5X2.7X3.1, NECK 3.1, NECK TO SAC RATIO WAS 1:1.4. THE PROCEDURE WAS COMPLETED WITH THE SAME SIZE COIL. THERE WAS NO ADVERSE EVENT, AND NO FURTHER INFORMATION. THE ADMITTING DIAGNOSIS WAS MRA. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE ORBIT MINI COMPLEX FILL 2.5X3.5 COIL WAS STRETCHED DURING THE INSERTION INTO THE ANEURYSM. DURING THE EVENT, THE COIL AND NON-CORDIS (MC) MICROCATHETER WERE REMOVED AS A UNIT FROM THE PATIENT. NO ADDITIONAL TORQUE OR MANIPULATION WAS UTILIZED DURING THE TIME THE COIL WAS BEING DELIVER OR REMOVED. AN EV3 HYPERFORM 4X7 BALLOON WAS USED DURING THE PROCEDURE. AFTER REMOVAL, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. DURING PLACEMENT OF THE COIL, NO RESISTANCE OCCURRED DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING, AND BEFORE STRETCHING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, NO RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED. ONCE THE DEVICES WERE REMOVED FROM THE PATIENT, THE COIL REMAINED ATTACHED ON THE DELIVERY SYSTEM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES.

    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 15092391

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER AND BALLOON.