BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2052412 · Received April 13, 2011

    Report

    Report Number
    1058196-2011-00161
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 25, 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING AN EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL ((B)(4)) STRETCHED DURING PLACEMENT IN THE ANEURYSM. THERE IS NO FURTHER INFORMATION REGARDING THE STRETCHING AND REMOVAL OF THE SYSTEM; HOWEVER, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE COIL OF THE RETURNED DEVICE REMAINED ATTACHED TO THE DELIVERY WIRE. 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. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES, AND THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED IN THE MICROCATHETER OR AT ANY OTHER TIME. IT WAS REPORTED THAT THE ANTERIOR COMMUNICATING MEASURED 5.9X6.3, NECK 4 AND NECK TO SAC RATIO WAS 1.5. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES. NO FURTHER INFORMATION REGARDING PROCEDURAL FACTORS PERTAINING TO THE STRETCHING OF THE COIL IS AVAILABLE. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. KINKS/BENDS WERE NOTED IN THE HYPOTUBE. INTRODUCER WAS ZIPPED AND SUPPORT COIL, GRIPPER AND PART OF EMBOLIC COIL WERE INSIDE OF IT. EMBOLIC COIL WAS STRETCHED AT PROXIMAL SIDE. AT UNAIDED EYE THE GRIPPER PRESENTED NO DAMAGES. NO OTHER ANOMALIES WERE NOTED. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND NO ANOMALIES WERE NOTED WHILE THE EMBOLIC COIL PRESENTED STRETCHED AND KINKS SECTIONS. 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 15193816 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED STRETCHED COIL WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE REPORT THAT THERE WERE NO DAMAGES NOTED PRIOR TO USE, NO RESISTANCE DURING INSERTION THROUGH THE MICROCATHETER, AND IT OCCURRED DURING PLACEMENT IN THE ANEURYSM, IT IS POSSIBLE THAT PROCEDURAL FACTORS INCLUDING WIDE NECK ANEURYSM CHARACTERISTIC AND MANIPULATION CONTRIBUTED. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE DAMAGE IS RELATED TO THE MANUFACTURING PROCESS. IN ADDITION INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE ON TRUFILL DCS COILS FROM LEAVING THE FACILITY. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL (B)(4) STRETCHED DURING PLACEMENT IN THE ANEURYSM. 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. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES, AND THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED IN THE MICROCATHETER OR AT ANY OTHER TIME. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES. THE TARGET SITE WAS THE A-COM THAT WAS TORTUOUS, AND THE ANEURYSM MEASURE 5.9X6.3, NECK 4, AND THE NECK O SAC RATION WAS 1.5. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 15193816

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR MICROCATHETER