BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2082008 · Received May 9, 2011

    Report

    Report Number
    1058196-2011-00211
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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

    THE REPORT FROM THE (B)(4) STUDY INDICATED THAT DURING THE PROCEDURE THE ORBIT RDFL COMPLEX FILL COIL ((B)(4)) COULD NOT BE DETACHED. THE DCS SYRINGE WAS CHANGED; HOWEVER THE COIL STILL WAS NOT ABLE TO BE DETACHED AND IT UNRAVELED DURING REMOVAL. THE DEVICE WAS REMOVED WITH THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. IT WAS EXCHANGED FOR A NEW COIL WHICH WAS SUCCESSFULLY DETACHED WITH AN UNKNOWN SYRINGE. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE EVENT. IT IS UNKNOWN IF THE SAME DCS SYRINGES USED WITH THE COIL THAT DID NOT DETACH WAS USED WITH PREVIOUS COILS OR SUBSEQUENT COILS. THERE WERE NO DAMAGES NOTED TO THE SYRINGE. THE SYRINGE WAS CONNECTED PROPERLY TO THE COIL DELIVERY SYSTEM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNKNOWN MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE WHEN THE COIL SYSTEM WAS INSERTED INTO THE MICROCATHETER. THERE IS NO FURTHER CLINICAL OR PROCEDURAL INFORMATION AVAILABLE. THE TRUFILL DCS ORBIT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE ROOT CAUSE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB, AND THE Y CONNECTOR OR TUOHY WAS CLOSED AFTER THE INTRODUCER WAS CORRECTLY SEATED IN THE HUB TO PREVENT MOVEMENT. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. AFTER REMOVAL FROM THE PATIENT, NEITHER DEVICE (ENTERPRISE DELIVERY SYSTEM (DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC)), STENT (STRUT UPLIFT OR DEFORMED, ETC), OR MICROCATHETER WERE DAMAGED. THE COIL UNRAVELED DURING REMOVAL/WITHDRAWAL FROM THE ANEURYSM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO KINKS WERE NOTED IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. OTHER THAN THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FROM THE (B)(4) INDICATED THAT THE PATIENT UNDERWENT COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE VRD OF AN UNKNOWN SITE, THE ENTERPRISE WAS INSERTED IN THE Y CONNECTOR WHEN THE ENTERPRISE STENT DEPLOYED PREMATURELY. THE PROCEDURE WAS CONTINUED USING A NEW PRODUCT. THE ORBIT RDFL COMPLEX FILL COIL (638CF0824) COULD NOT BE DETACHED. AFTER THE DCS SYRINGE (DETAIL UNKNOWN) WAS CHANGED, THE COIL WAS STILL UNABLE TO BE DETACHED AND ALSO UNRAVELED. THE COIL WAS REMOVED AND CHANGED, AND THE NEW COIL WAS SUCCESSFULLY DETACHED WITH UNKNOWN SYRINGE. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE EVENT, BUT IT WAS UNKNOWN IF THE SAME DCS SYRINGES WERE UTILIZED TO DETACH OTHER COILS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MICROCATHETER AND DCS SYRINGE