BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2032410 · Received March 29, 2011

    Report

    Report Number
    1058196-2011-00123
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED IN TANGLED CONDITION WITH THE EMBOLIC COIL INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED PARTIALLY ZIPPED AND RESIDUES OF DRY BLOOD COULD BE OBSERVED ON IT. PART OF THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL WAS FOUND WITH SEVERAL KINKS, NO DAMAGES WERE FOUND IN THE GRIPPER AND THE EMBOLIC COIL WAS FOUND KINKED/STRETCHED/BROKEN AND PART OF IT WAS STILL ATTACHED TO THE GRIPPER. THE ID FROM THE INTRODUCER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION ACCORDING TO DOCUMENT (B)(4). THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND APPEARS THAT IT WAS STRETCHED/KINKED BEFORE IT WAS BROKEN/SEPARATED. 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 "DCS " RESISTANCE/FRICTION, COULD NOT BE EVALUATED DUE THE CONDITIONS OF THE RECEIVED PRODUCT. THE FAILURE REPORTED BY THE COSTUMER AS "COIL " FRACTURED IN PATIENT, WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE COIL BROKEN AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. INSPECTIONS ARE IN PLACE THAT PREVENTS 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 THIS RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL ((B)(4)) WENT A FEW CENTIMETERS IN THE ANEURYSM, HOWEVER IT COULD NOT BE PUSHED IN FURTHER OR EASILY WITHDRAWN, AND IT GOT STUCK IN THE ECHELON MICROCATHETER (MC). THE COIL WHICH WAS REMOVED AS A UNIT WITH THE MICROCATHETER WAS STRETCHED. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM AFTER REMOVAL FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS GOOD WITH NO REPORTED ADVERSE EVENT. THERE WERE NO DAMAGES NOTED IN THE MC WHICH WAS USED TO CONTINUE THE PROCEDURE. THE TARGET SITE WAS A LEFT SUPRACLINOID INTERNAL CAROTID ARTERY ANEURYSM. NO VESSEL OR ANEURYSM SIZE/CHARACTERISTICS OR PROCEDURAL FILMS ARE AVAILABLE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE/FRICTION AT ANYTIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC AND NO KINKS IN THE MC. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT OF THE COIL, NO RESISTANCE OCCURRED DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. ONE TO ONE RELATIONSHIP BETWEEN THE COIL & DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, NO RESISTANCE OCCURRED AS THE COIL WAS ADVANCED; THERE WAS NO POSITIONING DIFFICULTY. ONCE THE COIL DID NOT BE PUSHED ANY FURTHER, NO ADDITIONAL TORQUE OR MANIPULATION WAS PERFORMED IN AN ATTEMPT TO PLACE THE COIL AT THE SITE. DURING THE ATTEMPT TO PLACE COIL, THE COIL WAS NOT KINKED, BENT OR PROLAPSED. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. 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 15189248 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED IN TANGLED CONDITION WITH THE EMBOLIC COIL INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED PARTIALLY ZIPPED AND RESIDUES OF DRY BLOOD COULD BE OBSERVED ON IT. PART OF THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL WAS FOUND WITH SEVERAL KINKS, NO DAMAGES WERE FOUND IN THE GRIPPER AND THE EMBOLIC COIL WAS FOUND KINKED/STRETCHED/BROKEN AND PART OF IT WAS STILL ATTACHED TO THE GRIPPER. THE ID OF THE INTRODUCER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND APPEARS THAT IT WAS STRETCHED/KINKED BEFORE IT WAS BROKEN/SEPARATED. THE REPORTED RESISTANCE/FRICTION WITH THE DEVICE COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RETURNED DEVICE. STRETCHING OF THE COIL WAS CONFIRMED. BASED ON THE REPORT THAT THE COIL WAS STRETCHED BUT STILL ATTACHED TO THE DELIVERY SYSTEM AFTER REMOVAL FROM THE PATIENT, THE BROKEN CONDITION OF THE COIL AND DAMAGES ON THE DELIVERY SYSTEM APPEAR TO HAVE OCCURRED DUE TO POST PROCEDURAL HANDLING. THE TIMING OF THE STRETCHED COIL AS RELATED TO THE ADVANCING AND WITHDRAWAL DIFFICULTY CANNOT BE DETERMINED. IT IS POSSIBLE THAT PROCEDURAL FACTORS, VESSEL/ANEURYSM CHARACTERISTICS CONTRIBUTED TO THE EVENT; HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE EVENT. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING PLACEMENT OF THE COIL, NO RESISTANCE OCCURRED DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, NO RESISTANCE OCCURRED WITH THE COIL WAS ADVANCED. THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. NO DAMAGES WERE NOTED ON THE MICROCATHETER, AND IT WAS NOT RE-SHAPED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM AFTER REMOVAL FROM THE PATIENT. THE TARGET SITE WAS THE LEFT SUPRACLINOID (ICA) INTERNAL CAROTID ANEURYSM. MEDICATION WAS GIVEN PRE, INTRA, AND POST PROCEDURE. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS GOOD. A CD COPY OF THE PROCEDURE WAS NOT AVAILABLE. NO ADDITIONAL INFORMATION WAS 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 15189248 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. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL (638CF1030) WENT A FEW CENTIMETERS IN THE ANEURYSM, HOWEVER IT COULD NOT BE PUSHED IN FURTHER OR EASILY WITHDRAWN, AND IT GOT STUCK IN THE ECHELON (MC) MICROCATHETER. THE COIL HAD TO BE EVENTUALLY REMOVED AND IT GOT STRETCHED DURING PLACEMENT. AFTER THE EVENT, BOTH THE COIL AND MICROCATHETER WERE REMOVED AS A UNIT. THERE WAS NO POSITIONING DIFFICULTY. ONCE THE COIL DID NOT BE PUSHED ANY FURTHER, NO ADDITIONAL TORQUE OR MANIPULATION WAS PERFORMED IN AN ATTEMPT TO PLACE THE COIL AT THE SITE. DURING THE ATTEMPT TO PLACE COIL, THE COIL WAS NOT KINK, BEND OR PROLAPSED. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, NO RESISTANCE OCCURRED AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM.

    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 15189248

    Patients

    Seq Age Sex Outcome Treatment
    1