BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2123354 · Received June 14, 2011

    Report

    Report Number
    1058196-2011-00291
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE INTRODUCER OF A TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. EMBOLIC COIL AND PART OF THE GRIPPER WERE INSIDE OF IT. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER. DELIVERY SYSTEM AND SUPPORT COIL WERE NOT PROVIDED FOR EVALUATION. PART OF THE GRIPPER WAS PROTRUDING FROM THE INTRODUCER'S DOTTED LINE AND A BLUE AND SMALL SECTION COULD BE OBSERVED, IT APPEARS TO BE PART OF THE SUPPORT COIL WHICH WAS BROKEN. GRIPPER AND BROKEN SECTION WERE INSPECTED UNDER MICROSCOPE AND WAS NOTED THAT GRIPPER WAS ELONGATED WHILE THE BROKEN SECTION INDICATES THAT THE SUPPORT COIL WAS BROKEN. EMBOLIC COIL PRESENTED STRETCHED SECTIONS. 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 15088067 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FIRST FAILURE REPORTED AS "PREMATURE DETACHMENT" WAS NOT CONFIRMED SINCE THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER; WHILE THE SECOND FAILURE (IMPEDED-IN MICROCATHETER) COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. HOWEVER, THE SUPPORT COIL WAS FOUND BROKEN. BROKEN SECTION APPEARS TO BE CAUSED BY THE ELONGATION PRESENTED, OCCASIONED WHEN EXCESSIVE FORCE WAS APPLIED CAUSING THAT THE SUPPORT COIL COME APART FROM THE REST OF THE DEVICE. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL AND HANDLING FACTORS APPEAR TO BE CONTRIBUTED IN THE REPORTED FAILURES. 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 COIL (638CS0721, LOT 15088067) WAS RECEIVED DETACHED INSIDE OF A COIL INTRODUCER, NO DELIVERY SYSTEM WAS RECEIVED. VISUAL INSPECTION DOES NOT SHOW ANY EVIDENCE OF COIL DAMAGE. A 0.016" MANDREL WAS INSERTED INTO THE INTRODUCER AND THE COIL MOVED FREELY. WITHOUT THE DELIVERY SYSTEM OR MICROCATHETER THERE IS LITTLE THAT CAN BE DONE TO DETERMINE THE CAUSE OF THE FRICTION OR THE REASON FOR THE PREMATURE DETACHMENT. THE UNIT WILL BE SENT FOR ADDITIONAL ANALYSIS. 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 15088067 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A CEREBRAL ANEURYSM COIL EMBOLIZATION THE ORBIT RDFL COMPLEX STANDARD WAS IMPEDED IN THE MICRO CATHETER AND HAD PREMATURE DETACHMENT. DURING A COIL EMBOLIZATION PROCEDURE OF A GIANT 3CM ANEURYSM OF THE BASILAR TIP, THE ORBIT RDFL COMPLEX STANDARD ((B)(4)) WAS DIFFICULT TO LOAD INTO A PROWLER LPES 90 DEGREE (MC) MICROCATHETER ((B)(4)), AND DID NOT ADVANCE ALL THE WAY TO THE END OF THE OF THE MC (APPROXIMATELY 20CM), AND IT WAS DECIDED TO REMOVE THE COIL SYSTEM. IT SEEMS LIKE THE DETACHMENT SEGMENT WAS THE PROBLEM. AFTER IT WAS REMOVED AND RE-SHEATHED, THE COIL WAS DETACHED IN THE DELIVERY SYSTEM. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE COIL OR DELIVERY SYSTEM (COIL DELIVERY SYSTEMS- FRACTURES, SEPARATED, KINKS, BENDS, ETC, DISTAL TIPS -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, COILS-FRACTURE, SEPARATED, STRETCHED, UNRAVELED, KINK, BEND, ETC), OR MICROCATHETER. THERE WAS NO REPORTED INJURY FOR THE PATIENT. A NON-STERILE INTRODUCER OF A TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE EMBOLIC COIL AND PART OF THE GRIPPER WERE INSIDE OF IT. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER. DELIVERY SYSTEM AND SUPPORT COIL WERE NOT PROVIDED FOR EVALUATION. PART OF THE GRIPPER WAS PROTRUDING FROM THE INTRODUCER'S DOTTED LINE AND A BLUE AND SMALL SECTION COULD BE OBSERVED, IT APPEARS TO BE PART OF THE SUPPORT COIL WHICH WAS BROKEN. GRIPPER AND BROKEN SECTION WERE INSPECTED UNDER MICROSCOPE AND WAS NOTED THAT GRIPPER WAS ELONGATED WHILE THE BROKEN SECTION INDICATES THAT THE SUPPORT COIL WAS BROKEN. EMBOLIC COIL PRESENTED STRETCHED SECTIONS. 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 15088067 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FIRST FAILURE REPORTED AS "PREMATURE DETACHMENT" WAS NOT CONFIRMED SINCE THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER; WHILE THE SECOND FAILURE (IMPEDED-IN MICROCATHETER) COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. HOWEVER, THE SUPPORT COIL WAS FOUND BROKEN. BROKEN SECTION APPEARS TO BE CAUSED BY THE ELONGATION PRESENTED, OCCASIONED WHEN EXCESSIVE FORCE WAS APPLIED CAUSING THE SUPPORT COIL TO COME APART FROM THE REST OF THE DEVICE. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL AND HANDLING FACTORS APPEAR TO BE CONTRIBUTED IN THE REPORTED FAILURES. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE FIRST FAILURE REPORTED AS "PREMATURE DETACHMENT" WAS NOT CONFIRMED SINCE THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER; WHILE THE SECOND FAILURE (IMPEDED-IN MICROCATHETER) COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. HOWEVER, THE SUPPORT COIL WAS FOUND BROKEN. BROKEN SECTION APPEARS TO BE CAUSED BY THE ELONGATION PRESENTED, OCCASIONED WHEN EXCESSIVE FORCE WAS APPLIED CAUSING THE SUPPORT COIL TO COME APART FROM THE REST OF THE DEVICE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL AND HANDLING ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED AND CONFIRMED EVENTS.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF A GIANT 3CM ANEURYSM OF THE BASILAR TIP, THE ORBIT RDFL COMPLEX STANDARD (638CS0721) WAS DIFFICULT TO LOAD INTO A PROWLER LPES 90 DEGREE (MC) MICROCATHETER (606-S155X/15218589), AND DID NOT ADVANCE ALL THE WAY TO THE END OF THE OF THE MC (APPROXIMATELY 20CM), AND IT WAS DECIDED TO REMOVE THE COIL SYSTEM. IT SEEMS LIKE THE DETACHMENT SEGMENT WAS THE PROBLEM. AFTER WE REMOVED AND RE-SHEATHED, THE COIL WAS DETACHED IN THE DELIVERY SYSTEM. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE COIL OR DELIVERY SYSTEM (COIL DELIVERY SYSTEMS- FRACTURES, SEPARATED, KINKS, BENDS, ETC, DISTAL TIPS -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, COILS-FRACTURE, SEPARATED, STRETCHED, UNRAVELED, KINK, BEND, ETC, OR MICROCATHETER. NO FURTHER INFORMATION WAS AVAILABLE.

    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 15088067

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR PROWLER LPES 90 DEGREE