BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2071913 · Received April 28, 2011

    Report

    Report Number
    1058196-2011-00182
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING AN EMBOLIZATION PROCEDURE, THE FIRST ORBIT RDFL COMPLEX STANDARD COIL ((B)(4)) WOULD NOT DETACHED AT THE TARGET SITE, AND THE ENTIRE SYSTEM (COIL AND DELIVERY SYSTEM) WAS REMOVED FROM THE PATIENT. THE SAME TRUFILL DCS SYRINGE II ((B)(4)) WAS NOT UTILIZED WITH OTHER PRODUCTS TO COMPLETE THE PROCEDURE. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE FAILURE TO DETACH OCCURRED WITH THE FIRST COIL; THEREFORE ANOTHER SYRINGE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE SYRINGE WAS CONNECTED PROPERLY WITH THE DELIVERY SYSTEM HUB. PRIOR TO THE FAILURE TO DETACHED, THE SYRINGE WAS NOT TAKING PAST THE GREEN ZONE, POSITION 3 OR RED ZONE, AND NO LEAKS WERE NOTICED ANYWHERE ON THE DELIVERY SYSTEM OR SYRINGE. THE ALTERNATIVE DETACHMENT METHOD WAS ATTEMPTED. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE, COIL (KINK, BEND, FRACTURE, SEPARATED, DETACHED, ETC), OR DELIVERY SYSTEM (KINK, BEND, FRACTURE, SEPARATED, ETC), AND THE COIL WAS STILL ATTACHED TO DELIVERY SYSTEM. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE TARGET SITE WAS THE SMOOTH CAROTID OPHTHALMIC ANEURYSM WITH A GIANT ANEURYSM OF THE OPHTHALMIC ARTERY. OTHER COILS (CODMAN) WERE UTILIZED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND BROKEN AS WELL AS KINKS WERE ON IT. THE INTRODUCER WAS RECEIVED PARTIALLY ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE RECEIVED SEPARATED FROM THE UNIT IN A (B)(4) BAG. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND KINKED/STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND KINKED/STRETCHED. THE HYPOTUBE WAS INSPECTED UNDER MICROSCOPE AND APPEARS THAT IT WAS KINKED BEFORE IT WAS BROKEN/SEPARATED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. (HYPOTUBE BROKE). 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 FAILURE TO DETACH COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF RECEIVED PRODUCT. THE CONDITIONS OF THE RETURNED DEVICE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE DUE TO THE CONDITIONS OF THE HYPOTUBE (BROKE). DAMAGE TO THE DELIVERY SYSTEM PRIOR TO ATTEMPT TO DETACH THE COIL MAY IMPACT THE ABILITY TO DETACH; HOWEVER, IT WAS REPORTED THAT THERE WERE NO DAMAGES NOTED TO THE DEVICE AFTER REMOVAL FROM THE PATIENT. THE CAUSE OF THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER BASED ON THE REPORTED INFORMATION IT OCCURRED POST PROCEDURAL HANDLING. THE CONCOMITANT SYRINGE WAS NOT RECEIVED FOR ANALYSIS; WITH REVIEW OF THE ANALYSIS OF THE RETURNED DEVICE AND AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND BROKE AS WELL AS KINKS WERE ON IT. THE INTRODUCER WAS RECEIVED PARTIALLY ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE RECEIVED SEPARATED OF THE UNIT IN A (B)(4) BAG. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND KINKED/STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND KINKED/STRETCHED. THE HYPOTUBE WAS INSPECTED UNDER MICROSCOPE AND APPEARS THAT IT WAS KINKED BEFORE IT WAS BROKEN/SEPARATED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. (HYPOTUBE BROKE). 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- FAILURE TO DETACH" COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF RECEIVED PRODUCT; THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE DUE TO THE CONDITIONS OF THE HYPOTUBE (BROKE). THE CAUSE OF THE DAMAGES 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 THESE DAMAGES. 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.

    Additional Manufacturer Narrative · 1

    DURING AN EMBOLIZATION PROCEDURE, THE FIRST ORBIT RDFL COMPLEX STANDARD COIL ((B)(4)) WOULD NOT DETACHED AT THE TARGET SITE, AND THE ENTIRE SYSTEM (COIL AND DELIVERY SYSTEM) WAS REMOVED FROM THE PATIENT. THE SAME SYRINGE WAS NOT UTILIZED WITH OTHER PRODUCTS TO COMPLETE THE PROCEDURE. THE FAILURE TO DETACH OCCURRED WITH THE FIRST COIL, THEREFORE ANOTHER SYRINGE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE SYRINGE WAS CONNECTED PROPERLY WITH EACH DELIVERY SYSTEM HUB. PRIOR TO THE FAILURE TO DETACHED, THE SYRINGE WAS NOT TAKING PAST THE GREEN ZONE, POSITION 3 OR RED ZONE, AND NO LEAKS WERE NOTICED ANYWHERE ON THE DELIVERY SYSTEM OR SYRINGE. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE, COIL (KINK, BEND, FRACTURE, SEPARATED, DETACHED, ETC), OR DELIVERY SYSTEM (KINK, BEND, FRACTURE, SEPARATED, ETC), AND THE COIL WAS STILL ATTACHED TO DELIVERY SYSTEM. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE TARGET SITE WAS THE SMOOTH CAROTID OPHTHALMIC ANEURYSM WITH A GIANT ANEURYSM OF THE OPHTHALMIC ARTERY. OTHER COILS (CODMAN) WERE UTILIZED TO COMPLETE THE PROCEDURE. THE SYRINGE IS GOING TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED (B)(4) 2011.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX STANDARD COIL (638CS2030) PRESENTED TECHNICAL PROBLEMS AT THE MOMENT OF ITS RELEASE, EVEN AFTER ALL THE MOVEMENT TO PERFORM ITS COMPLETE RELEASE WITH THE TRUFILL DCS SYRINGE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15133479

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE