BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2082474 · Received May 10, 2011

    Report

    Report Number
    1058196-2011-00223
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PLEASE NOTE THAT THE PRODUCT CATALOG SHOULD BE 638MF0410. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A COIL EMBOLIZATION PROCEDURE THE ORBIT COMPLEX FILL COIL BECAME UNRAVELED/STRETCHED. THERE ARE NO PATIENT OR TARGET LESION DETAILS AVAILABLE TO DATE. DURING COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) WAS ADVANCED INTO MICROCATHETER, THE PHYSICIAN FOUND THE COIL WAS STRETCHED UNDER X-RAY. THEN THE PHYSICIAN WITHDREW THE COIL AND CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EV 3 (MC) MICROCATHETER AT ALL TIMES, AND AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. THE MC WAS RE-SHAPED PRIOR TO USE WITH THE SHAPING MANDREL AND STEAM. NO DAMAGES WERE NOTICED AFTER IT WAS RESHAPED. NO RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER, AND NO KINKS WERE NOTED IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. 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. DURING REPOSITIONING, THE COIL WAS NOT 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 SYSTEMS. 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 KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGED. PART OF THE SUPPORT COIL WAS RECEIVED OUTSIDE OF THE INTRODUCER THE REST OF IT, GRIPPER AND EMBOLIC COIL WERE RECEIVED INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED/KINKED AND IT WAS STILL ATTACHED TO THE GRIPER. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE. THE GRIPPER WAS FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED/KINKED. 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 MICROSCOPIC ANALYSIS. THE CAUSE OF THE KINKS FOUND ON THE DEVICE AND THE EMBOLIC COIL CONDITION (STRETCHED/KINKED) 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 COMPLAINT OF UNRAVELED/STRETCHED, AS WELL AS NOTED KINKS ON THE DEVICE WAS CONFIRMED ON ANALYSIS; HOWEVER, THESE DAMAGES WERE UNRELATED TO THE MANUFACTURING PROCESS. ALL DEVICES 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 LIMITED INFORMATION SUGGESTS THAT PROCEDURAL AND HANDLING ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE.

    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 15236984: 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. 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.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL (640CX0410) WAS ADVANCED INTO MICROCATHETER, THE PHYSICIAN FOUND THE COIL WAS STRETCHED UNDER X-RAY. THEN THE PHYSICIAN WITHDREW THE COIL AND CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THE PATIENT WAS FINE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EV 3 (MC) MICROCATHETER AT ALL TIMES, AND AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. THE MC WAS RE-SHAPED PRIOR TO USE WITH THE SHAPING MANDREL AND STEAM. NO DAMAGES WERE NOTICED AFTER IT WAS RESHAPED. NO RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER, AND NO KINKS WERE NOTED IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. 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. DURING REPOSITIONING, THE COIL WAS NOT 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 SYSTEMS.

    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 15236984

    Patients

    Seq Age Sex Outcome Treatment
    1 EV 3 MICROCATHETER