BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2103224 · Received May 25, 2011

    Report

    Report Number
    1058196-2011-00253
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 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

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00253 AND 1058196-2011-00254. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT INDICATED DURING A COIL EMBOLIZATION PROCEDURE OF THE A-COM, THE FIRST ORBIT COMPLEX FILL 7X21 COIL ((B)(4)/LOT UNKNOWN) UNRAVELED AFTER IT WAS ADVANCED AND PULLED BACK REPEATEDLY IN THE EXCELSIOR SL-10/BOSTON SCIENTIFIC MICROCATHETER. THE COIL SYSTEM WAS REMOVED FROM THE PATIENT. AN ORBIT RDFL COMPLEX FILL COIL ((B)(4)) THEN STUCK IN THE MIDDLE PORTION OF THE SAME MICROCATHETER. WHEN THE COIL WAS PULLED BACK FOR REMOVAL, IT WAS STUCK AND STOPPED ADVANCING AND THEN SEPARATED IN THE MICROCATHETER. THE ENTIRE SYSTEM, COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND CHANGED TO OTHER NEW PRODUCTS. THERE IS NO INFORMATION AVAILABLE REGARDING THE ANEURYSM SIZE OR CHARACTERISTICS. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE OTHER PRODUCTS WITHOUT PATIENT INJURY. THERE WERE NO CALCIFICATION OR TORTUOSITY IN THE VESSEL, AND NO FURTHER INFORMATION WAS AVAILABLE. ONE NON-CORDIS MICROCATHETER (NOT RESHAPED, EXCELSIOR SL-10, BOSTON SCIENTIFIC) WITH ONE EMBOLIC COIL STUCK IN THE DISTAL TIP OF THE DEVICE WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE NON-CORDIS MICROCATHETER WAS INSPECTED AND IT WAS FOUND KINKED AT 11CM FOR THE DISTAL END. THE EMBOLIC COIL WAS FOUND STRETCHED/KINKED. THE DISTAL END OF THE BOSTON SCIENTIFIC MICROCATHETER WAS INSPECTED AND AN EMBOLIC COIL WAS FOUND STUCK OF IT. THE EMBOLIC COIL WAS FOUND STRETCHED/KINKED AND BROKEN. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND APPEARS THAT IT WAS KINKED BEFORE IT WAS BROKEN/SEPARATED. THE NON-CORDIS MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND THE REST OF THE EMBOLIC COIL WAS EXPULSED FROM THE DISTAL TIP OF THE NON-CORDIS MICROCATHETER. 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 REPORTED IMPEDANCE OF THE COIL SYSTEM IN THE MICROCATHETER COULD NOT BE FULLY EVALUATED SINCE THE DELIVERY SYSTEM WAS NOT RETURNED. THE COIL WAS CONFIRMED TO BE SEPARATED. THE CAUSE OF THE COIL SEPARATION AND THE DAMAGES FOUND ON IT COULD NOT BE CONCLUSIVE DETERMINED; HOWEVER THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURES FROM LEAVING THE FACILITY. IT IS POSSIBLE THAT PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS AND KINKING OF THE CONCOMITANT DEVICE MAY HAVE CONTRIBUTED. HOWEVER, NO DEFINITIVE CONCLUSION CAN BE MADE. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT INDICATED DURING A COIL EMBOLIZATION PROCEDURE OF THE A-COM, THE FIRST ORBIT COMPLEX FILL 7X21 COIL (637CF0721/LOT UNKNOWN) UNRAVELED AFTER IT WAS ADVANCED AND PULLED BACK REPEATEDLY IN THE MICROCATHETER (NOT RESHAPED, EXCELSIOR SL-10, BOSTON SCIENTIFIC). THE COIL SYSTEM WAS REMOVED FROM THE PATIENT, AND AN ORBIT RDFL COMPLEX FILL COIL 638CF0615 (COMPLAINT PRODUCT) WAS USED FOR THE PROCEDURE. DURING DELIVERY, THE COIL WAS STUCK IN THE MIDDLE PORTION OF THE MICROCATHETER. WHEN THE COIL WAS PULLED BACK FOR REMOVAL, IT WAS STUCK AND STOPPED ADVANCING AND THEN SEPARATED IN THE MICROCATHETER. ALL THE SYSTEM (COIL AND MC) WERE REMOVED FROM THE PATIENT AND CHANGED TO OTHER NEW PRODUCTS. AFTER THE EVENT WITH THE FIRST COIL (637CF0721), THE SAME MICROCATHETER WAS UTILIZED WITH THE NEXT COIL SYSTEM (638CF0615). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE OTHER PRODUCTS WITHOUT PATIENT INJURY. THERE WERE NO CALCIFICATION AND TORTUOSITY IN THE VESSEL, AND NO FURTHER INFORMATION WAS AVAILABLE.

    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 15213641

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL-10 MICROCATHETER