BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1834380 · Received September 15, 2010

    Report

    Report Number
    1058196-2010-00270
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE SECOND ORBIT HELICAL FILL 3X6 COIL COULD NOT BE DEPLOYED FROM THE DELIVERY SYSTEM. AFTER THE COIL DID NOT DETACH THE ALTERNATIVE DETACHMENT ZONE (RED) WAS UTILIZED TO ATTEMPT TO DETACH THE COIL. THE COIL WAS REMOVED AND ANOTHER COIL WAS INSERTED AND PLACED SUCCESSFULLY. PRIOR TO THIS COIL, ZONE# 3 WAS EXCEEDED ONCE, BUT THE ALTERNATE ZONE (RED) WAS NOT EXCEEDED. DURING PREP, A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL AND PREP THE SYRINGE. THE SYRINGE WAS TAKEN TO THE BLUE ZONE, AND THE BLUE ZONE WAS NOT EXCEEDED. THE PRODUCT WAS CONNECTED PROPERLY TO THE HUB OF THE COIL DELIVERY SYSTEM. NO LEAKAGE WAS NOTED AT THE CONNECTOR, EXTENSION TUBING, DELIVERY SYSTEM HUB OR ANYWHERE ELSE, AND THE CONNECTOR WAS CHECKED FOR PROPER SEATING/FITTING ON THE DELIVERY SYSTEM HUB. AFTER DISCONNECTING THE COIL DELIVERY SYSTEM, NO DAMAGES WERE NOTED ON THE SYRINGE. AFTER THE SECOND COIL WAS REMOVED, THE SAME SYRINGE WAS UTILIZED TO DETACH THE NEXT COIL. AFTER THE PRODUCT FAILURE OCCURRED, NO DAMAGES WERE NOTED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED, ETC), COIL (UNRAVELED, STRETCHED, KINK, BEND, ETC), OR ANY SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM PRIOR TO SHIPPING. A CONSTANT FLUSH WAS MAINTAINED THROUGH THE DEVICES. NO FURTHER INFORMATION WAS AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS FINAL ASSEMBLY LOT AND COIL SUBASSEMBLY LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING EMBOLIC COIL ATTACHMENT PULL TEST AND EMBOLIC COIL DETACHMENT PRESSURE. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. HYPOTUBE WAS INSPECTED AND SEVERAL BENDS AND KINKS WERE FOUND ON IT. THE SUPPORT COIL WAS INSIDE OF THE INTRODUCER. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER, AND IT PRESENTED NO DAMAGES. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON EITHER THE GRIPPER OR COIL. USING A LAB SAMPLE TRUFILL DCS SYRINGE II (B)(4), THE DEVICE WAS PURGED BY INCREASING PRESSURE TO THE BLUE ZONE. AFTER THAT THE PRESSURE WAS INCREASED AT THE GREEN ZONE AT WHICH POINT THE EMBOLIC COIL WAS DETACHED WITHOUT ANY ANOMALY. 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 REPORTED FAILURE OF THE COIL TO DETACH WAS NOT CONFIRMED DURING FUNCTIONAL ANALYSIS. THE CAUSE OF THE BENDS AND KINKS IN THE HYPOTUBE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, INSPECTIONS ARE IN PLACE AS TO PREVENT THESE KINDS OF FAILURES LEAVING FROM THE FACILITY. PROCEDURAL AND HANDLING FACTORS APPEAR TO BE CONTRIBUTED TO THE EVENT REPORTED; THERE WAS NO DISCREPANCY WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS FINAL ASSEMBLY LOT AND COIL SUBASSEMBLY LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING EMBOLIC COIL ATTACHMENT PULL TEST AND EMBOLIC COIL DETACHMENT PRESSURE. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE REPORTED PROCEDURAL INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE REPORTED INABILITY TO DETACH THE ORBIT COIL. THERE ARE NO IDENTIFIED MANUFACTURING ISSUES WITH REVIEW OF THE DEVICE HISTORY RECORDS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SECOND ORBIT HELICAL FILL 3X6 COIL COULD NOT BE DEPLOYED FROM THE DELIVERY SYSTEM. THE COIL WAS REMOVED AND ANOTHER COIL WAS INSERTED AND PLACED SUCCESSFULLY. DURING PREP, A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL AND PREP THE SYRINGE. THE SYRINGE WAS TAKING TO THE BLUE ZONE, AND THE BLUE ZONE WAS NOT EXCEEDED. PRIOR TO THIS COIL, ZONE# 3 WAS EXCEEDED ONCE, BUT THE ALTERNATE ZONE (RED) WAS NOT EXCEEDED. AFTER THE COIL DID NOT DETACHED, THE ALTERNATIVE DETACHMENT ZONE (RED) WAS UTILIZED TO ATTEMPT TO DETACH THE COIL. THE PRODUCT WAS CONNECTED PROPERLY TO THE HUB OF THE COIL DELIVERY SYSTEM. NO LEAKAGE WAS NOTED AT THE CONNECTOR, EXTENSION TUBING, DELIVERY SYSTEM HUB OR ANYWHERE ELSE, AND THE CONNECTOR WAS CHECKED FOR PROPER SEATING/FITTING ON THE DELIVERY SYSTEM HUB. AFTER DISCONNECTING THE COIL DELIVERY SYSTEM, NO DAMAGES WERE NOTED ON THE SYRINGE. AFTER THE SECOND COIL WAS REMOVED, THE SAME SYRINGE WAS UTILIZED TO DETACH THE NEXT COIL. AFTER THE PRODUCT FAILURE OCCURRED, NO DAMAGES WERE NOTED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED, ETC), COIL (UNRAVELED, STRETCHED, KINK, BEND, ETC), OR ANY SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM PRIOR TO SHIPPING. A CONSTANT FLUSH WAS MAINTAINED THROUGH THE DEVICES. NO FURTHER INFORMATION WAS AVAILABLE.

    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. 13470668

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR DCS SYRINGE