BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2081420 · Received May 9, 2011

    Report

    Report Number
    1058196-2011-00210
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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

    DURING A COIL EMBOLIZATION PROCEDURE OF THE LEFT INTERNAL ILIAC ARTERY, AFTER 6 COILS WERE DELIVERED IN SELECT LP-ES 150/5 CM MICROCATHETER (B)(4) AND PLACED IN THE TARGET LESION, THE ORBIT RDFL COMPLEX STANDARD COIL (B)(4) WAS USED AS 7TH COIL, BUT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER (MC) LARGE FRICTION WAS FELT AT APPROXIMATELY 50CM DISTAL TO THE HUB AND THE COIL STOPPED ADVANCING. THE COIL WAS REMOVED FROM THE PATIENT AS A UNIT WITH THE MC. AFTER FLUSHING, THE GUIDEWIRE (AGOSAL, ST JUDE MEDICAL) WAS INSERTED IN MC AGAIN. THEN ANOTHER ATTEMPT WAS MADE TO DELIVER THE COIL IN THE MC, BUT FRICTION WAS STILL FELT. THE COMPLETE SYSTEM WAS REMOVED FROM THE PATIENT. DURING REMOVAL THE COIL WAS UNRAVELED. A NEW COIL AND MICROCATHETER (DETAILS UNKNOWN) WERE USED TO CONTINUE THE PROCEDURE WITH NO DIFFICULTY DELIVERING THE COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT INJURY. AFTER THE RESISTANCE WAS NOTED, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE THE COIL THROUGH THE MC. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE MC WAS NOT RE-SHAPED PRIOR TO USE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEMS. NO FURTHER 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 KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. PART OF THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER WITHOUT DAMAGE, THE REST OF IT THE SUPPORT COIL WAS FOUND OUTSIDE OF THE INTRODUCER. THE GRIPPER AND THE EMBOLIC COIL INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED ON THEM. THE OD OF THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. (PART OF THE SUPPORT COIL OUTSIDE OF THE INTRODUCER AND KINKS FOUND ON THE HYPOTUBE.) 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. DUE TO THE CONDITION OF THE RETURNED DEVICE THE REPORTED INABILITY TO INSERT THE COIL THROUGH THE MICROCATHETER COULD NOT BE EVALUATED WITH FUNCTIONAL TESTING. THE TIMING OF THE KINKS NOTED ON THE DEVICE COULD NOT BE DETERMINED, BUT MAY HAVE CONTRIBUTED TO THE INSERTION DIFFICULTY. THERE IS NO INDICATION THAT THE KINKS ARE RELATED TO THE MANUFACTURING PROCESS, AND MAY BE RELATED TO PROCEDURAL OR POST PROCEDURAL FACTORS. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE FACILITY. THE REPORTED STRETCHED CONDITION OF THE COIL AFTER REMOVAL WAS NOT CONFIRMED WITH ANALYSIS OF THE DEVICE. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 15277890 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 A COIL EMBOLIZATION PROCEDURE OF THE LEFT INTERNAL ILIAC ARTERY, AFTER 6 COILS WERE DELIVERED IN SELECT LP-ES 150/5 CM (MC) MICROCATHETER (606-S155X) AND PLACED IN THE TARGET LESION, THE COIL ORBIT RDFL COMPLEX STANDARD (638CS1030) WAS USED AS 7TH COIL, BUT WHEN THE COIL WAS ADVANCED IN THE MC LARGE FRICTION WAS FELT AT APPROXIMATELY 50CM DISTAL TO THE HUB AND THE COIL STOPPED ADVANCING. THE COIL WAS REMOVED FROM THE PATIENT AS A UNIT, AND AFTER FLUSHING THE GUIDEWIRE (AGOSAL, ST JUDE MEDICAL) WAS INSERTED IN MC AGAIN. THEN ANOTHER ATTEMPT WAS MADE TO DELIVER THE COIL IN THE MC, BUT FRICTION WAS STILL FELT. ALL THE SYSTEM WAS REMOVED FROM THE PATIENT, AND CHANGED TO OTHER NEW PRODUCTS (DETAIL UNKNOWN). DURING REMOVAL, THE COIL WAS UNRAVELED. THE OTHER NEW COIL WAS DELIVERED IN THE OTHER NEW MC WITHOUT ANY DIFFICULTY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT INJURY. AFTER THE RESISTANCE WAS NOTED, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE THE COIL THROUGH THE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. AFTER THE EVENT, THE MICROCATHETER AND COIL DELIVERY SYSTEM WAS REMOVED AS A UNIT. THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE MC WAS NOT RE-SHAPED PRIOR TO USE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEMS. ACCESS WAS MADE FROM RIGHT FEMORAL ARTERY. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. 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 15277890

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SELECT LP-ES MICROCATHETER