BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1962632 · Received January 18, 2011

    Report

    Report Number
    1058196-2011-00035
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    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

    DURING A COIL EMBOLIZATION PROCEDURE OF A PARA-OPHTHALMIC NARROW NECK ANEURYSM WITH A NARROW NECK, THE SL 10 MICROCATHETER WAS IN THE CENTER OF THE ANEURYSM WHEN A TRUFILL COMPLEX COIL (6MMX15 CM) WAS BEING DEPLOYED. THE FIRST 7-8 CM WAS DEPLOYED EASILY, BUT THE NEXT TURN OF COIL BACKED OUT INTO THE PARENT INTERNAL CAROTID ARTERY. WHILE TRYING TO PULL THE COIL BACK INTO THE ANEURYSM THE COIL STRETCHED, AND THE COIL WAS RETRIEVED WITH SOME DIFFICULTY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NOT RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. THE ANEURYSM SIZE WAS 6X15. 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. SEVERAL BENDS WERE NOTED IN THE HYPOTUBE. SUPPORT COIL PRESENTED KINKS AND IT WAS OUT OF INTRODUCER. GRIPPER WAS PROTRUDING FROM THE CUT-LINE OF THE INTRODUCER AND IT PRESENTED COMPRESSED SECTIONS. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS INSIDE OF THE INTRODUCER, IN ADDITION IT WAS STRETCHED FROM PROXIMAL SIDE. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND TWO COMPRESSED SECTIONS WERE CONFIRMED. EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND THE STRETCHED CONDITION WAS CONFIRMED, NO OTHER ANOMALIES WERE FOUND. 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 15206137 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. REPORTED FAILURE BY THE CUSTOMER AS 'COIL UNRAVELED-STRETCHED' WAS CONFIRMED DURING THE ANALYSIS. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE DAMAGES NOTED IN THE DEVICE COULD BE CAUSED DURING THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. ADDITIONALLY ACCORDING (B)(4) INVESTIGATION THE CUSTOMER STATE THAT 'DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NOT RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS' THIS SUGGEST THAT THE STRETCHED CONDITION IN THE EMBOLIC COIL OCCUR DURING THE PROCEDURE. IN ADDITION, THE DAMAGES NOTED IN THE GRIPPER APPEAR TO BE CAUSED BY AN INADEQUATE HANDLING OF THE UNIT, WHEN IT WAS PULLED BACK THROUGH THE INTRODUCER. PROCEDURAL AND HANDLING FACTORS APPEAR TO BE IMPACTED ON THE FAILURE REPORTED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN ANEURYSM EMBOLIZATION REPAIR PROCEDURE THE TRUFILL COMPLEX COIL UNRAVELED / STRETCHED DURING PLACEMENT. NO PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED TO DATE. THE TARGET ANEURYSM FOR THE PROCEDURE WAS A PARA-OPHTHALMIC NARROW NECK ANEURYSM. THE ANEURYSM SIZE WAS 6X15. A SL 10 MICROCATHETER WAS PLACED IN THE CENTER OF THE ANEURYSM. THEN THE PHYSICIAN PROCEEDED WITH A TRUFILL COMPLEX COIL (6MMX15CM) DEPLOYMENT. THE FIRST 7-8CM WAS DEPLOYED EASILY, BUT THE NEXT TURN OF COIL BACKED OUT INTO THE PARENT VESSEL, INTERNAL CAROTID ARTERY. WHILE TRYING TO PULL THE COIL BACK INTO THE ANEURYSM, THE COIL STRETCHED. THE PHYSICIAN THEN BEGAN WITHDRAWAL; HOWEVER, THE COIL WAS RETRIEVED WITH SOME DIFFICULTY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NOT RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. SEVERAL BENDS WERE NOTED IN THE HYPOTUBE. SUPPORT COIL PRESENTED KINKS AND IT WAS OUT OF INTRODUCER. GRIPPER WAS PROTRUDING FROM THE CUT-LINE OF THE INTRODUCER AND IT PRESENTED COMPRESSED SECTIONS. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS INSIDE OF THE INTRODUCER, IN ADDITION, IT WAS STRETCHED FROM PROXIMAL SIDE. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND TWO COMPRESSED SECTIONS WERE CONFIRMED. EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND THE STRETCHED CONDITION WAS CONFIRMED, NO OTHER ANOMALIES WERE FOUND. 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 15206137 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. REPORTED FAILURE BY THE CUSTOMER AS 'COIL UNRAVELED-STRETCHED' WAS CONFIRMED DURING THE ANALYSIS. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE DAMAGES NOTED IN THE DEVICE COULD BE CAUSED DURING THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. ADDITIONALLY ACCORDING (B)(4) INVESTIGATION THE CUSTOMER STATE THAT 'DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NOT RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS' THIS SUGGEST THAT THE STRETCHED CONDITION IN THE EMBOLIC COIL OCCUR DURING THE PROCEDURE. IN ADDITION, THE DAMAGES NOTED IN THE GRIPPER APPEAR TO BE CAUSED BY AN INADEQUATE HANDLING OF THE UNIT, WHEN IT WAS PULLED BACK THROUGH THE INTRODUCER. PROCEDURAL AND HANDLING FACTORS APPEAR TO BE IMPACTED ON THE FAILURE REPORTED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. REPORTED FAILURE BY THE CUSTOMER AS 'COIL UNRAVELED-STRETCHED' WAS CONFIRMED DURING THE ANALYSIS. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE DAMAGES NOTED IN THE DEVICE COULD BE CAUSED DURING THE MANUFACTURING PROCESS. 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 PROCEDURAL AND HANDLING ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED UNRAVELED/STRETCHED EVENT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF A PARA-OPHTHALMIC NARROW NECK ANEURYSM WITH A NARROW NECK, THE SL 10 MICROCATHETER WAS IN THE CENTER OF THE ANEURYSM WHEN A TRUFILL COMPLEX COIL (6MMX15CM) WAS BEING DEPLOYED. THE FIRST 7-8CM WAS DEPLOYED EASILY, BUT THE NEXT TURN OF COIL BACKED OUT INTO THE PARENT INTERNAL CAROTID ARTERY. WHILE TRYING TO PULL THE COIL BACK INTO THE ANEURYSM THE COIL STRETCHED, AND THE COIL WAS RETRIEVED WITH SOME DIFFICULTY.

    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 15206137

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER