BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1954484 · Received January 10, 2011

    Report

    Report Number
    1058196-2011-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN ELECTIVE COIL EMBOLIZATION, WHEN PLANNING TO IMPLANT THE THIRD COIL, A TRUFILL DCS ORBIT MINI COMPLEX FILL 2 X 2 COIL USING A BOSTON SL10 MICROCATHETER, THE PHYSICIAN EXPERIENCED 'DIFFICULTY TO CROSS.' WHEN WITHDRAWN, IT WAS NOTED THAT THE COIL WAS STRETCHED; IT WAS NOT DETACHED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY. PRIOR TO THE EVENT, A 4X8 EV3 COIL AND A 3X4 TRUFILL ORBIT COIL HAD BEEN SUCCESSFULLY IMPLANTED IN THE SACCULAR ANEURYSM WHICH WAS REPORTED TO BE: HEIGHT 4 MM; WIDTH 4 MM; LENGTH 3.5 MM; AND NECK 2 MM. THE NECK TO SAC RATION WAS REPORTED TO BE 60%. NECK RE-MODELING WAS NOT USED. WITH ADDITIONAL INVESTIGATION IT WAS REPORTED THAT THERE WAS NO RESISTANCE/FRICTION BETWEEN THE GUIDEWIRE AND THE MICROCATHETER OR COIL DURING ADVANCEMENT WITHOUT FURTHER CLARIFICATION REGARDING THE REPORTED 'DIFFICULTY TO CROSS.' AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MICROCATHETER AT ALL TIMES. THE MICROCATHETER WAS RE-SHAPED PRIOR TO USE. THE MICROCATHETER WAS NOT REPOSITIONED WHILE THE COIL WAS DEPLOYED OUT OF THE DISTAL END. THE PRODUCT WAS RETURNED FOR INSPECTION. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS UNZIPPED WITHOUT DAMAGES AND SUPPORT COIL AND GRIPPER WERE OUT OF THE INTRODUCER. EMBOLIC COIL WAS NOT PROVIDED FOR EVALUATION. KINKS WERE NOTED IN THE HYPOTUBE. THE SUPPORT COIL PRESENTED NO DAMAGES. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT (KINKS IN HYPOTUBE AND LACK OF COIL). 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 15176109 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED STRETCHED CONDITION OF THE COIL COULD NOT BE EVALUATED SINCE THE COIL WAS NOT RECEIVED. FURTHER FUNCTIONAL TESTING FOR ADVANCEMENT THROUGH THE MICROCATHETER OR THE REPORTED 'DIFFICULTY TO CROSS' COULD NOT BE EVALUATED DUE TO THE RECEIVED CONDITION OF THE DEVICE (KINKS IN HYPOTUBE AND LACK OF EMBOLIC COIL). THE CAUSE OF THE DAMAGES NOTES IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. IN ADDITION, IT WAS REPORTED THAT NO DAMAGES WERE NOTED PRIOR TO USE. INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES LEAVING FORM THE FACILITY. IT IS POSSIBLE THAT THE WIDE NECKED ANEURYSM CHARACTERISTICS WITHOUT THE USE OF NECK REMODELING MAY HAVE REQUIRED DEVICE MANIPULATION THAT CONTRIBUTED TO THE EVENT. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND DUE TO THE CONDITION OF THE RECEIVED PRODUCT THE CAUSE OF THE REPORTED EVENT REMAINS INCONCLUSIVE AND UNDETERMINED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN SUCCESSFULLY IMPLANTED/DEPLOYED TWO COILS AND WHILE ATTEMPTING TO DELIVER ANOTHER TRUFILL DCS ORBIT MINI COMPLEX FILL 2 X 2 COIL, HE EXPERIENCED DIFFICULTY ACCESSING/CROSSING THE TARGET LESION. WHEN HE WITHDREW THE COIL, HE FOUND THAT IT WAS DROPPED FROM THE DELIVERY SYSTEM/WIRE. THE PHYSICIAN THEN USED ANOTHER COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. A BOSTON SCIENTIFIC SL10 MICROCATHETER WAS USED FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS ELECTIVE. THE SECULAR ANEURYSM SIZE WAS REPORTED TO BE: HEIGHT 4 MM; WIDTH 4 MM; LENGTH 3.5 MM; AND NECK 2 MM. THE NECK TO SAC RATION WAS REPORTED TO BE 60%. NECK RE-MODELING WAS NOT USED. THERE WAS NO REPORTED RESISTANCE/FRICTION BETWEEN THE GUIDEWIRE AND THE MICROCATHETER OR COIL DURING ADVANCEMENT. AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MICROCATHETER AT ALL TIMES. THE MICROCATHETER WAS RE-SHAPED PRIOR TO USE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR BOSTON SCIENTIFIC SL10 MICROCATHETER