BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1871371 · Received October 15, 2010

    Report

    Report Number
    1058196-2010-00295
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    FRICTION OCCURRED WHEN THE 5X10 TRUFILL DCS ORBIT COMPLEX FILL COIL, WAS ADVANCED INTO THE UNKNOWN MICROCATHETER. THE DELIVERY SYSTEM WAS PULLED BACK AND THE COIL BECAME STRETCHED. THE COIL WAS REMOVED SUCCESSFULLY. A SECOND COIL WAS ADVANCED INTO THE MICROCATHETER WITHOUT ANY DIFFICULTY. THE PROCEDURE WAS COMPLETED USING OTHER COILS WITHOUT ANY PATIENT INJURY. THE TARGET SITE WAS AN ANEURYSM OF THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY WITHOUT VESSEL CALCIFICATION OR TORTUOSITY. ACCESS SITE WAS FEMORAL ARTERY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. NO KINKS IN THE MC WERE NOTED THAT MAY HAVE CONTRIBUTED TO THE EVENT. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. IT IS NOT KNOWN AT WHAT POINT DURING THE DELIVERY THROUGH THE MICROCATHETER THE RESISTANCE WAS ENCOUNTERED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. ACCESS SITE WAS FEMORAL ARTERY. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. EMBOLIC COIL WAS STRETCHED AND TANGLED WITH THE REST OF THE DEVICE. INTRODUCER WAS ZIPPED AND LOCATED AT THE DISTAL SIDE OF THE DEVICE. PART OF THE GRIPPER AND THE EMBOLIC COIL THAT IS STRETCHED, WERE INSIDE OF THE INTRODUCER WHILE THE SUPPORT COIL WAS OUT AND PRESENTED A KINK. GRIPPER APPEARS TO BE COMPRESSED DUE TO IS WAS STUCK IN THE INTRODUCER. HYPOTUBE PRESENTED KINKED SECTIONS. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. DEVICE WAS INSPECTED UNDER MICROSCOPE AND A COMPRESS SECTION WAS NOTED ON THE PROXIMAL SIDE OF THE GRIPPER. EMBOLIC COIL WAS FOUND TOTALLY STRETCHED. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. 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 15157608 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED STRETCHED COIL WAS CONFIRMED. THE REPORTED FRICTION DURING INSERTION COULD NOT BE EVALUATED DUE TO THE RETURNED CONDITION OF THE DEVICE. THE KINKS NOTED IN THE HYPOTUBE, EMBOLIC COIL AND INTRODUCER AND STRETCHED CONDITION IN THE EMBOLIC COIL COULD HAVE IMPACTED REPORTED EVENT. HOWEVER, IT CANNOT BE DETERMINED WHEN THESE DAMAGES OCCURRED AS RELATED TO THE EVENT. IT WAS REPORTED THAT THERE WERE NO OTHER DAMAGES NOTED ON THE DEVICE WHEN REMOVED. NEITHER THE ANALYSIS NOR THE DHR REVIEW INDICATES THAT THESE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. IN ADDITION THE DEVICE OD IS WITHIN SPECIFICATION. PROCEDURAL AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED RESISTANCE; HOWEVER, THERE ARE NO IDENTIFIED FACTORS BASED ON THE AVAILABLE INFORMATION. PROCEDURAL FACTORS, DEVICE INTERACTION WITH THE CONCOMITANT MICROCATHETER APPEAR TO HAVE CONTRIBUTED TO THE STRETCHED COIL. THE CAUSE OF THE RESISTANCE/FRICTION CANNOT BE DETERMINED. NO CONCLUSION CAN BE MADE; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE COIL (B)(4) (COMPLAINT PRODUCT) WAS ADVANCED IN THE (MC) MICROCATHETER (DETAIL UNKNOWN). FRICTION OCCURRED BETWEEN THE COIL AND THE MICROCATHETER DURING DELIVERY, BUT NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS PULLED BACK AND THE COIL BECAME STRETCHED (UNRAVELED). THE COIL WAS REMOVED SUCCESSFULLY AND CHANGED TO OTHER NEW COIL (SAME SIZE, DETAIL UNKNOWN). THE OTHER COIL WAS ADVANCED IN THE MC WITHOUT ANY DIFFICULTY. THE PROCEDURE WAS COMPLETED USING OTHER COILS WITHOUT ANY PATIENT INJURY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO KINKS IN THE MC WERE NOTED THAT MAY HAVE CONTRIBUTED TO THE EVENT. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCKED TO SECURE THE DELIVERY SYSTEM. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE TARGET SITE WAS THE (IC) INTERNAL CAROTID- OPHTHALMIC ARTERY ANEURYSM WAS NOT CALCIFIED AND NOT TORTUOUS. . ACCESS SITE WAS FEMORAL ARTERY. 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. 15157608

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR MICROCATHETER