BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2022229 · Received March 17, 2011

    Report

    Report Number
    1058196-2011-00104
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 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 SPLENIC ARTERY COIL EMBOLIZATION, THE ORBIT COMPLEX FILL 5X10 COIL ((B)(4)) COULD NOT BE DETACHED BY THE TRUFILL DCS SYRINGE (LOT UNKNOWN) AT THE GREEN ZONE, AND COULD NOT BE DETACHED WHEN THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THE COIL REMOVED WITH THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. THE DEVICE WAS CHANGED TO OTHER NEW PRODUCT, WHICH WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT INJURY. AFTER THE FAILURE TO DETACH, THE SAME SYRINGE WAS NOT UTILIZED WITH THE NEXT COIL, AND NO DAMAGES WERE NOTICED ON ANY OF THE SYRINGE. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND NO DAMAGES WERE NOTICED DURING THIS PERIOD. NO DAMAGES WERE NOTED ON THE HUB OF THE COIL DELIVERY SYSTEM. AFTER REMOVAL FROM THE PATIENT, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND NO FURTHER INFORMATION WAS AVAILABLE. THE ORBIT COIL SYSTEM AND CONCOMITANT SYRINGE WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE ORBIT LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15206133 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE INVOLVED DEVICES AND BASED ON THE AVAILABLE INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED FAILURE OF THE ORBIT COIL TO DETACH WITH THE TRUFILL DCS SYRINGE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 15206133 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. 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 RESULTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION OF A SPLENIC ARTERY, THE ORBIT COMPLEX FILL 5X10 COIL (B)(4) COULD NOT BE DETACHED BY THE DCS SYRINGE(LOT UNKNOWN) AT THE GREEN ZONE, AND COULD NOT BE DETACHED IT EVEN WHEN THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THE COIL WAS CHANGED TO OTHER NEW PRODUCT, AND IT WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT INJURY. AFTER THE FAILURE TO DETACH, THE SAME SYRINGE WAS NOT UTILIZED WITH THE NEXT COIL, AND NO DAMAGES WERE NOTICED ON ANY OF THE SYRINGE. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND NO DAMAGES WERE NOTICED DURING THIS PERIOD. NO DAMAGES WERE NOTED ON THE HUB OF THE COIL DELIVERY SYSTEM. AFTER REMOVAL FROM THE PATIENT, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COIL (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND 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. NA 15206133

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE