BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2050898 · Received April 12, 2011

    Report

    Report Number
    1058196-2011-00160
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 30, 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 15093319 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 # 14096547, 14085705 AND 14085706 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW OF THESE LOTS NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THESE LOTS. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT COMPLEX FILL COIL STRETCHED DURING PLACEMENT IN THE ANEURYSM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EXCELSIOR SL-10 (MC) MICROCATHETER AT ALL TIMES, AND THE MC WAS NOT KINKED. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED IN THE MC. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. 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. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES. THE TARGET SITE WAS THE DISTAL (ICA) INTERNAL CAROTID ARTERY THAT WAS NORMAL AND A SACULAR ANEURYSM THAT MEASURED 7.3X7.5, NECK 3.5, AND A NECK TO SAC RATIO WAS 3.5/7.4. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE IS NO FURTHER INFORMATION. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND KINKS WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGED. 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. THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED THROUGH THE INTRODUCER UNDER MICROSCOPE. THE GRIPPER WAS FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED. 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 FAILURE REPORTED BY THE COSTUMER AS "COIL - UNRAVELED/STRETCHED" WAS CONFIRMED. THE CAUSE OF THE COIL STRETCHED AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE AS PER (B)(4) THAT PREVENT THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE FAILURE REPORTED STRETCHED COIL WAS CONFIRMED. THE CAUSE OF THE EMBOLIC COIL STRETCHED AND HYPOTUBE KINKED COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND DEVICE MANIPULATION 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 A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL (B)(4) STRETCHED DURING PLACEMENT IN THE ANEURYSM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EXCELSIOR SL-10 (MC) MICROCATHETER AT ALL TIMES, AND THE MC WAS NOT KINKED THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED IN THE MC. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. 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. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES. THE TARGET SITE WAS THE DISTAL (ICA) INTERNAL CAROTID ARTERY THAT WAS NORMAL AND A SACULAR ANEURYSM THAT MEASURED 7.3*7.5, NECK 3.5, AND A NECK TO SAC RATIO WAS 3.5/7.4. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE IS NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15093319

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR EXCELSIOR SL-10 MICROCATHETER