BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2091882 · Received May 17, 2011

    Report

    Report Number
    1058196-2011-00241
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A COIL EMBOLIZATION PROCEDURE THE TRUFILL COIL BECAME UNRAVELED/STRETCHED. THERE ARE NO PATIENT OR TARGET LESION DETAILS AVAILABLE TO DATE. DURING THE PROCEDURE, THE TRUFILL COIL ((B)(4)) STRETCHED DURING PLACEMENT. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES, AND THE MICROCATHETER WAS NOT RE-SHAPED. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED THROUGH THE MICROCATHETER OR KINKS. NO BALLOON OR STENT REMODELING PRODUCT WAS USED DURING THE PROCEDURE. 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 DEVICE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTED. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS ZIPPED AND PRESENTED NO DAMAGES. EMBOLIC COIL WAS OUT OF THE INTRODUCER, IT WAS STILL ATTACHED TO THE GRIPPER AND IT PRESENTED A STRETCHED CONDITION ON THE PROXIMAL SIDE. GRIPPER AND SUPPORT COIL WERE INSIDE OF THE INTRODUCER AND NO DAMAGES WERE NOTED AT UNAIDED EYE. SOME WAVES WERE NOTED IN THE HYPOTUBE. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED IN THE GRIPPER WHILE THE EMBOLIC COIL PRESENTED KINKED AND 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 15202048 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. REPORTED FAILURE BY THE CUSTOMER AS "COIL STRETCHED" WAS CONFIRMED. THE CAUSE OF THE REPORTED COMPLAINT AND THE DAMAGES FOUND ON THE DEVICE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS DUE TO (B)(4) INVESTIGATION THE CUSTOMER STATED THAT "THE COIL UNRAVELED STRETCHED DURING PLACEMENT IN THE ANEURYSM" AND THERE WERE NO DAMAGES REPORTED AFTER REMOVE THE DEVICE FROM THE PACKAGE. IN ADDITION INSPECTIONS ARE IN PLACE THAT PREVENTS THAT THIS TYPE OF DAMAGES ON TRUFILL DCS COILS FROM LEAVES THE FACILITY. PRODUCT HANDLING AND/OR PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE EVENT AS REPORTED; THEREFORE NO CORRECTIVE ACTION WAS TAKEN. THE COMPLAINT OF UNRAVELED/STRETCHED WAS CONFIRMED ON ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. KINKS WERE NOTED ON THE DELIVERY SYSTEM UNDER INSPECTION, THESE MAYBE ATTRIBUTED TO THE HANDLING THAT OCCURRED EITHER DURING THE PROCEDURE OR DURING SHIPPING POST PROCEDURE. THE IFU CAUTIONS "TRUFILL DCS ORBIT DETACHABLE COILS ARE DELICATE DEVICES AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE SYSTEM FOR BENDS OR KINKS. DO NOT USE A COIL SYSTEM THAT SHOWS SIGNS OF DAMAGE." REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE TRUFILL COIL (B)(4) STRETCHED DURING PLACEMENT. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES, AND THE MICROCATHETER WAS NOT RE-SHAPED. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED THROUGH THE MICROCATHETER OR KINKS. NO BALLOON OR STENT REMODELING PRODUCT WAS USED DURING THE PROCEDURE. 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 DEVICE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15202048

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER