BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2221493 · Received August 24, 2011

    Report

    Report Number
    1058196-2011-00423
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS FOUND KINKED. THE INTRODUCER WAS FOUND UNZIPPED AND KINKED, AND RESIDUES OF DRY BLOOD COULD BE OBSERVED INSIDE OF IT. SOME 28CM OF THE EMBOLIC COIL SYSTEM WAS FOUND OUTSIDE OF THE INTRODUCER, THE GRIPPER AND THE SUPPORT COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL WAS FOUND KINKED AND GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. WITH MICROSCOPIC INSPECTION THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. 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 RESISTANCE FRICTION COULD NOT BE EVALUATED WITH FUNCTIONAL TESTING DUE TO THE RETURNED CONDITION OF THE DEVICE; HOWEVER, THE DIMENSIONAL ANALYSIS FOUND THE DEVICE OD MEETS SPECIFICATIONS. WITH ANALYSIS OF THE RETURNED DEVICE, THE COIL WAS FOUND TO BE STRETCHED. WITH REVIEW OF THE ANALYSIS OF THE CONCOMITANT MICROCATHETER THE COMPRESSED SECTION ON THE MICROCATHETER THAT APPEARS TO BE DUE TO PROCEDURAL FACTORS IS A FACTOR THAT LIKELY CONTRIBUTED TO THE REPORTED EVENT AND STRETCHING OF THE COIL. ADDITIONALLY THE RESIDUES OF BLOOD FOUND WITHIN THE COIL INTRODUCER MAY BE AN INDICATION THAT INADEQUATE MAINTENANCE OF A CONTINUOUS FLUSH AS OUTLINED IN THE INSTRUCTIONS FOR USE MAY HAVE CONTRIBUTED. BASED ON THE ANALYSIS OF THE DEVICE, THE CAUSE OF THE REPORTED EVENT AND DAMAGES FOUND ON THE RETURNED COIL COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES FROM LEAVING THE FACILITY. PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE AFTER SUCCESSFUL PLACEMENT OF THREE COILS THERE WAS DIFFICULTY ADVANCING TWO 3X6 TRUFILL DCS ORBIT MINI COMPLEX FILL COIL (637MF0306 LOT 15069106 FOLLOWED BY LOT 15204573) THROUGH A PROWLER 14 MICROCATHETER. THE FIRST COIL 3X6 COIL WAS REMOVED INTACT, STILL ATTACHED TO THE DELIVERY SYSTEM, FROM THE MICROCATHETER. THE SECOND COIL WAS NOTED TO BE DETACHED IN THE MICROCATHETER WHEN IT WAS WITHDRAWN. THE MICROCATHETER AND COIL WERE REMOVED AS A UNIT. ANALYSIS OF THE COIL THAT WAS REMOVED INTACT FOUND THE COIL WAS STRETCHED. THERE WAS NO PATIENT INJURY. A NEW MICROCATHETER WAS USED WITH A NEW COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS EMBOLIZATION OF A 6X5 POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM.

    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 15069106

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER 14 CATHETER