BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2103161 · Received May 25, 2011

    Report

    Report Number
    1058196-2011-00252
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 6, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER WITHOUT DAMAGED. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED ON THEM. 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 NOT CONFIRMED DURING THE MICROSCOPIC ANALYSIS. THE CAUSE OF THE KINK 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; PROCEDURAL AND HANDLING FACTORS APPEAR TO HAVE CONTRIBUTED TO THIS DAMAGE. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENT 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 OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE, WHEN THE SURGEON WAS TRYING TO MAKE A FRAME WITH MULTIPLE TRIALS, THE COIL STRETCHED-OUT SO HE CAPTURED IT WITH THE MICROCATHETER AND PULLED BACK. LATER ON THE SAME PROCEDURE, HE FELT RESISTANCE ADVANCING ADDITIONAL MICROCATHETER INSIDE THE GUIDING CATHETER, SO HE EXCHANGED THE GUIDING CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EXCELSIOR (MC) MICROCATHETER AT ALL TIMES, HOWEVER THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. NO RESISTANCE WAS NOTED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER, AND THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. AFTER THE GUIDE CATHETER WAS EXCHANGE, THE SAME PRODUCT (EXCELSIOR MC) THAT HAD THE RESISTANCE WAS USED TO COMPLETE THE PROCEDURE. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO FURTHER INFORMATION WAS AVAILABLE.

    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 15155879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EXCELSIOR MICROCATHETER| EXCELSIOR MICROCATHETER