BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2202370 · Received August 11, 2011

    Report

    Report Number
    1058196-2011-00408
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 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 NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND SEVERAL KINKS ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGED. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE 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. SOME WAVES WERE NOTED ON THE DEVICE; HOWEVER THESE APPEAR TO OCCUR DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED 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 DURING THE ANALYSIS. THE CAUSE OF THE KINKS FOUND ON THE DEVICE AND THE EMBOLIC COIL CONDITION (STRETCHED) 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 THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT MINI COMPLEX FILL2.5X2.5 COIL ((B)(4)) STRETCHED DURING MULTIPLE ATTEMPTS TO PLACE THE COIL IN THE ANEURYSM, AND AFTER THE EVENT, ALL THE COIL AND DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. ANOTHER SAME SIZE TRUFILL COIL WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. DURING THE CASE, AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EXCELSIOR SL 10 (MC) MICROCATHETER STRAIGHT OR 45 DEGREES AT ALL TIMES, AND THE MICROCATHETER WAS NOT RE-SHAPED, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE OR CONTRIBUTED TO THE EVENT. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND SEVERAL KINKS ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGED. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND STILL ATTACHED TO THE GRIPPER. SOME WAVES WERE NOTED ON THE DEVICE; HOWEVER THESE APPEAR TO HAVE OCCURRED DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED 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 CUSTOMER AS "COIL - UNRAVELED/STRETCHED" WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE KINKS FOUND ON THE DEVICE AND THE EMBOLIC COIL CONDITION (STRETCHED) 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 THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE FAILURE REPORTED BY THE COSTUMER AS "COIL - UNRAVELED/STRETCHED" WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE KINKS FOUND ON THE DEVICE AND THE EMBOLIC COIL CONDITION (STRETCHED) COULD NOT BE CONCLUSIVELY DETERMINED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE.

    Additional Manufacturer Narrative · 1

    DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT MINI COMPLEX FILL2.5X2.5 COIL ((B)(4)) STRETCHED DURING MULTIPLE ATTEMPTS TO PLACE THE COIL IN THE ANEURYSM, AND AFTER THE EVENT, ALL THE COIL AND DELIVERY SYSTEMS WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. ANOTHER SAME SIZE TRUFILL COIL WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE THROUGH THE SAME EXCELSIOR SL 10 45 DEGREE (MC) MICROCATHETER (STRYKER). DURING THE CASE, AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. THE MC WAS NOT RE-SHAPED, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE OR CONTRIBUTED TO THE EVENT. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT MINI COMPLEX FILL 2.5X2.5 COIL (637MF2525/ 15107866) STRETCHED DURING MULTIPLE ATTEMPTS TO PLACE THE COIL IN THE ANEURYSM, AND AFTER THE EVENT, ALL THE COIL AND DELIVERY SYSTEMS WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. ANOTHER SAME SIZE TRUFILL COIL WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. DURING THE CASE, AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EXCELSIOR SL 10 (MC) MICROCATHETER STRAIGHT OR 45 DEGREES AT ALL TIMES, AND THE MICROCATHETER WAS NOT RE-SHAPED, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE OR CONTRIBUTED TO THE EVENT. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED.

    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 15107866

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR MICROCATHETER