BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1971137 · Received January 26, 2011

    Report

    Report Number
    1058196-2011-00041
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 16, 2010
    Report Date
    January 16, 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

    PLEASE NOTE THAT THE COILS COULD NOT BE DETACHED AT THE ALTERNATIVE DETACHMENT AREA OF THE SYRINGE. DURING A COIL EMBOLIZATION OF THE (VA-PICA) VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBRAL ARTERY, THE ORBIT MINI COMPLEX FILL 3X4 COIL ((B)(4)) COULD NOT BE DETACHED BY THE SYRINGE (LOT: 96331101 OR 96331105, (B)(4)) AT THE GREEN ZONE, AND COULD NOT BE DETACHED EVEN WHEN THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THE SYRINGE WAS CHANGED TO OTHER NEW PRODUCT (LOT: 96331101 OR 96331105, (B)(4)), BUT THE COIL STILL COULD NOT BE DETACHED. THE COIL WAS REMOVED AND CHANGED TO OTHER NEW COILS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER COILS WITHOUT ANY PATIENT INJURY. THE PRODUCTS WERE STORE PER LABELING INSTRUCTIONS, AND THE PACKAGES (INNER OR OUTER) WERE NOT DAMAGED. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGES. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR PREPPING ALL THE DEVICES. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICE IN ANY SECTION OF THE DEVICES (COIL-UNRAVELED, STRETCHED, KINK, BEND, ETC), AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS ZIPPED AND SUPPORT AND EMBOLIC COIL WERE INSIDE OF IT. RESIDUES OF A CLEAR LIQUID THAT APPEARS TO BE SALINE SOLUTION WERE NOTED INSIDE OF THE INTRODUCER. HYPOTUBE PRESENTED BENDS. EMBOLIC COIL WAS TRIED TO PUSH BUT IT WAS STUCK DUE TO THE CLEAR LIQUID. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED NO DAMAGES WHILE THE EMBOLIC COIL WAS STRETCHED. RESIDUES WERE REMOVED AND THEN THAT THE SUPPORT COIL AND EMBOLIC COIL WERE RETRIEVED FROM THE INTRODUCER; AFTER THAT THE TRUFILL DCS WAS PURGE USING A LAB SAMPLE SYRINGE (B)(4), THE PRESSURE WAS INCREASE UNTIL THE BLUE ZONE BUT THE PRESSURE WAS LOSING. DEVICE WAS INSPECTED AND AT THIS TIME WAS NOTICE THAT THE SUPPORT COIL WAS BROKEN AND THE PRESSURE WAS LOSING AT THIS POINT. 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 15162690 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. SEM WAS PERFORMED TO ANALYZE THE SURFACE OF THE DELIVERY WIRE. RESULTS SHOWED THAT THE DELIVERY WIRE PRESENTED EVIDENCE OF PULLING UNTIL FAILURE IN THE SUPPORT COIL; NO CUTTING CHARACTERISTICS WERE NOTED IN THE FRACTURE SURFACE OF THE WIRE (METAL ENDS). THE EXACT CAUSE OF THE POSSIBLE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITES DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE. THE REPORTED FAILURE BY THE CUSTOMER AS "COIL- FAILURE TO DETACH" WAS CONFIRMED. THE CAUSE OF THE FAILURE WAS THE BROKEN NOTED IN THE SUPPORT COIL. ACCORDING THE SEM ANALYSIS PERFORMED THE CAUSE OF THE BROKEN SECTION COULD BE A RESULT OF PULLING OF THE DEVICE. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE CAUSE DURING THE MANUFACTURING PROCESS. IN ADDITION INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KIND OF DAMAGES (BROKEN AND BEND IN THE HYPOTUBE) LEAVING FROM THE FACILITY. PROCEDURAL AND HANDLING FACTOR APPEARS TO BE CONTRIBUTED TO THE FAILURE EXPERIENCED BY THE CUSTOMER; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE 3X4 MINI COMPLEX FILL TRUFILL DCS ORBIT ((B)(4)) COIL COULD NOT BE DETACHED BY THE TRUFILL DCS SYRINGE (LOT 96331101 OR 96331105) WHEN PRESSURIZED TO THE GREEN ZONE FOLLOWED BY ATTEMPT USING THE ALTERNATIVE DETACHMENT METHOD. THE SYRINGE WAS CHANGED TO ANOTHER DEVICE (LOT: 96331101 OR 96331105) BUT THE COIL STILL COULD NOT BE DETACHED. THE COIL WAS REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM WITH NO DAMAGES TO THE COIL OR SYSTEM NOTED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS A VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBRAL ARTERY (VA-PICA) ANEURYSM. THE VESSEL WAS NOT CALCIFIED OR TORTUOUS. THE PRODUCTS WERE STORED PER LABELING INSTRUCTIONS, AND THE PACKAGES (INNER OR OUTER) WERE NOT DAMAGED. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGES. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR PREPPING ALL THE DEVICES. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICE IN ANY SECTION OF THE DEVICES. NO FURTHER INFORMATION IS AVAILABLE. 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 15162690 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS ZIPPED AND SUPPORT AND EMBOLIC COIL WERE INSIDE OF IT. RESIDUES OF A CLEAR LIQUID THAT APPEARS TO BE SALINE SOLUTION WERE NOTED INSIDE OF THE INTRODUCER. HYPOTUBE PRESENTED BENDS. WITH AN ATTEMPT TO PUSH THE EMBOLIC COIL OUT OF THE INTRODUCER, IT WAS STUCK DUE TO THE CLEAR LIQUID. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND THE GRIPPER PRESENTED NO DAMAGES WHILE THE EMBOLIC COIL WAS STRETCHED. RESIDUES WERE REMOVED AND THEN THAT THE SUPPORT COIL AND EMBOLIC COIL WERE RETRIEVED FROM THE INTRODUCER. AFTER THAT THE TRUFILL DCS WAS PURGED USING A LAB SAMPLE SYRINGE (B)(4), THE PRESSURE WAS INCREASED UNTIL THE BLUE ZONE; HOWEVER THE PRESSURE WAS LOST. THE DEVICE WAS INSPECTED AND AT THIS TIME WAS NOTICE THAT THE SUPPORT COIL WAS BROKEN AND THE PRESSURE LOSS WAS OCCURRING AT THIS POINT. SEM WAS PERFORMED TO ANALYZE THE SURFACE OF THE DELIVERY WIRE. RESULTS SHOWED THAT THE DELIVERY WIRE PRESENTED EVIDENCE OF PULLING UNTIL FAILURE IN THE SUPPORT COIL; NO CUTTING CHARACTERISTICS WERE NOTED IN THE FRACTURE SURFACE OF THE WIRE (METAL ENDS). THE EXACT CAUSE OF THE POSSIBLE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITES DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE. THE REPORTED FAILURE OF THE COIL TO DETACH WAS CONFIRMED. WITH ANALYSIS OF THE RETURNED DEVICE IT WAS DUE TO A BROKEN SECTION OF THE SUPPORT COIL WHICH COULD BE AS A RESULT OF PULLING OF THE DEVICE. NEITHER THE ANALYSIS NOR THE DEVICE HISTORY RECORD REVIEW SUGGESTS THAT THE FAILURE WAS CAUSED DURING THE MANUFACTURING PROCESS. IN ADDITION INSPECTIONS ARE IN PLACE TO PREVENT THESE KIND OF DAMAGES (BROKEN AND BEND IN THE HYPOTUBE) LEAVING FROM THE FACILITY. BASED ON THE INABILITY TO PRESSURIZE TO THE PURGE ZONE DURING ANALYSIS OF THE RETURNED DEVICE AND THE REPORT THAT THE DEVICE WAS PREPPED/PURGED WITHOUT DIFFICULTY, IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION OF THE (VA-PICA) VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBRAL ARTERY, THE ORBIT MINI COMPLEX FILL 3X4 COIL (637MF0304) COULD NOT BE DETACHED BY THE SYRINGE(LOT: 96331101 OR 96331105, PI#2) AT THE GREEN ZONE, AND COULD BE DETACHED EVEN WHEN THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THE SYRINGE WAS CHANGED TO OTHER NEW PRODUCT (LOT: 96331101 OR 96331105, PI#3), BUT THE COIL STILL COULD NOT BE DETACHED. THE COIL WAS REMOVED AND CHANGED TO OTHER NEW COILS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER COILS WITHOUT ANY PATIENT INJURY. THE PRODUCTS WERE STORE PER LABELING INSTRUCTIONS, AND THE PACKAGES (INNER OR OUTER) WERE NOT DAMAGED. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGES. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR PREPPING ALL THE DEVICES. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICE IN ANY SECTION OF THE DEVICES (COIL-UNRAVELED, STRETCHED, KINK, BEND, ETC), AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS.

    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 15162690

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGES