BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2022306 · Received March 17, 2011

    Report

    Report Number
    1058196-2011-00105
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS NOT RECEIVED. KINKS WERE NOTED IN THE HYPOTUBE AND SUPPORT COIL. THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER AND THE REST OF THE EMBOLIC COIL WAS NOT PROVIDED. GRIPPER WAS INSPECTED AND COMPRESSED AND ELONGATED SECTIONS WERE NOTED AS WELL THE BROKEN COIL COULD BE OBSERVED DUE TO ONLY THE HEADPIECE WAS ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. THE FIRST FAILURE REPORTED BY THE CUSTOMER AS "DCS RESISTANCE FRICTION" COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. THE SECOND FAILURE REPORTED AS "COIL UNRAVELED / STRETCHED" COULD NOT BE EVALUATED DUE TO IT WAS NOT RECEIVED. THE KINKS NOTED IN THE HYPOTUBE COULD BE IMPACTED IN THE FAILURE REPORTED. THE CAUSE OF THE KINKS, GRIPPER DAMAGES AND BROKEN COIL NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS IN ADDITION THAT THE DEVICE MEET WITH THE OD SPECIFICATION ACCORDING THE MANUFACTURING PROCEDURES. INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. SINCE THE FAILURE REPORTED COULD NOT BE EVALUATED AND THERE ARE NO INDICATION THAT THE FAILURE EXPERIENCED COULD BE RELATED TO THE MANUFACTURING PROCESS; THE FAILURE REPORTED REMAINS INCONCLUSIVELY AND UNDETERMINED THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION FOR (MAPCA) MAJOR AORTO-PULMONARY COLLATERAL ARTERIES, RESISTANCE WAS FELT WHEN THE ORBIT MINI COMPLEX FILL 4X10 COIL ((B)(4)) WAS ADVANCED IN THE MICROCATHETER (TRANSIT 2, DETAIL UNKNOWN). AFTER THE COIL WAS REMOVED, IT WAS FOUND THAT THE COIL WAS STRETCHED (UNRAVELED). THE COIL WAS SUCCESSFULLY REMOVED ENTIRELY. THE PROCEDURE WAS CONTINUED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE OTHER NEW COIL WITHOUT ANY PATIENT INJURY. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT RE-SHAPED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. IT IS UNKNOWN IN WHAT AREA OF THE MICROCATHETER THE RESISTANCE OCCURRED OR WHETHER ADDITIONAL FORCE WAS USED IN ATTEMPT TO ADVANCE THE DEVICE AFTER THE RESISTANCE OCCURRED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE (COIL FRACTURE, SEPARATED, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. NO ADDITIONAL TREATMENT WAS CONDUCTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. NO INFORMATION WAS PROVIDED ABOUT THE TARGET VESSEL'S CHARACTERISTICS. ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS NOT RECEIVED. KINKS WERE NOTED IN THE HYPOTUBE AND SUPPORT COIL. HEADPIECE WAS STILL ATTACHED TO THE GRIPPER AND THE REST OF THE EMBOLIC COIL WAS NOT PROVIDED. GRIPPER WAS INSPECTED AND COMPRESSED AND ELONGATED SECTIONS WERE NOTED AS WELL THE BROKEN COIL COULD BE OBSERVED DUE TO ONLY THE HEADPIECE WAS ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. 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 RESISTANCE/FRICTION DURING INSERTION OF THE ORBIT COIL INTO THE UNKNOWN TRANSIT MICROCATHETER COULD NOT BE EVALUATED SINCE THE MICROCATHETER WAS NOT RETURNED AND DUE TO THE CONDITION OF THE RETURNED ORBIT SYSTEM. IT IS POSSIBLE THAT PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS AND KINKING DURING PROCEDURAL USE CONTRIBUTED TO THE REPORTED RESISTANCE/FRICTION. ADDITIONALLY THE REPORTED STRETCHING OF THE COIL COULD NOT BE EVALUATED SINCE THE DEVICE WAS RECEIVED WITH THE COIL BROKEN FROM THE HEAD-PIECE. BASED ON THE REPORT THAT THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT, IT CAN BE CONCLUDED THAT THIS BROKEN CONDITION OF THE COIL OCCURRED POST PROCEDURAL USE AND THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS BASED ON THE ANALYSIS. THE CAUSE OF THE KINKS, GRIPPER DAMAGES AND BROKEN COIL NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. THE RETURNED DEVICE MET WITH THE OD SPECIFICATION ACCORDING THE MANUFACTURING PROCEDURES. AND INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. BASED ON THE INABILITY TO EVALUATE THE DEVICES FOR THE REPORTED EVENTS AND NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS; THE CAUSE OF THE EVENT REMAINS UNDETERMINED. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION FOR (MAPCA) MAJOR AORTO-PULMONARY COLLATERALS ARTERIES, RESISTANCE WAS FELT WHEN THE ORBIT MINI COMPLEX FILL 4X10 COIL ((B)(4)) WAS ADVANCED IN THE MICROCATHETER (TRANSIT 2, DETAIL UNKNOWN). AFTER THE COIL WAS REMOVED, IT WAS FOUND THAT THE COIL WAS STRETCHED (UNRAVELED). THE COIL WAS SUCCESSFULLY REMOVED ENTIRELY. THE PROCEDURE WAS CONTINUED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE OTHER NEW COIL WITHOUT ANY PATIENT INJURY. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE, ADDITIONALLY THE MICROCATHETER WAS NOT RE-SHAPED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE (COIL FRACTURE, SEPARATED, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. NO ADDITIONAL TREATMENT WAS CONDUCTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. NO INFORMATION WAS PROVIDED ABOUT THE TARGET VESSEL'S CHARACTERISTICS.

    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 15184491

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO TRANSIT MICROCATHETER