BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2052414 · Received April 13, 2011

    Report

    Report Number
    1058196-2011-00164
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 29, 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

    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 15217441 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH 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.

    Additional Manufacturer Narrative · 1

    DURING A TRANSCATHETER BRACHIAL ARTERY EMBOLIZATION THE TRUFILL DCS ORBIT (B)(4) COULD NOT BE DETACHED USING THE TRUFILL DCS SYRINGE (B)(4). THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EVENT. THE SYRINGE WAS PRESSURIZED TO THE GREEN ZONE FOLLOWED BY UTILIZING THE ALTERNATIVE DETACHMENT METHOD. THE COIL WAS REMOVED FROM THE PATIENT'S BODY AND REPLACED BY OTHER NEW PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EVENT. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES. PRIOR TO THE FAILURE TO DETACH, NO OTHER COILS HAD BEEN DETACHED WITH THE SYRINGE, SINCE THIS WAS THIS FIRST COIL. THE SYRINGE WAS CONNECTED PROPERLY WITH THE COIL DELIVERY SYSTEM HUB. NO LEAKS WERE NOTICED ANYWHERE ON THE DELIVERY SYSTEM OR SYRINGE. THE SAME SYRINGE WAS NOT UTILIZED WITH OTHER PRODUCTS. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE, COIL OR DELIVERY SYSTEM, AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE VESSEL WAS NOT CALCIFIED AND MODERATELY TORTUOUS. THE TRUFILL DCS COIL SYSTEM WAS NOT HAVE NOT FOR ANALYSIS 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 15217441 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST. BASED ON THE REPORTED PROCEDURAL INFORMATION THERE ARE NO IDENTIFIED FACTORS CONTRIBUTING TO THE REPORTED FAILURE OF THE COIL TO DETACH USING THE SYRINGE. WITHOUT THE RETURN OF THE DEVICES FOR ANALYSIS, NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TRANS-CATHETER ARTERIAL EMBOLIZATION OF THE BRONCHIAL ARTERY, THE COIL (B)(4) (COMPLAINT PRODUCT) COULD NOT BE DETACHED WITH THE DCS SYRINGE (635-002/LOT UNKNOWN). THE COIL WAS REMOVED FROM THE PATIENT'S BODY AND REPLACED BY OTHER NEW PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EVENT. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES. PRIOR TO THE FAILURE TO DETACH, NO OTHER COILS WERE DETACHED WITH THE SYRINGE, SINCE THIS WAS THIS FIRST COIL. THE SYRINGE WAS CONNECTED PROPERLY WITH EACH DELIVERY SYSTEM HUB. PRIOR TO THE FAILURE TO DETACHED, THE SYRINGE WAS TAKING PAST THE GREEN ZONE, POSITION 3. NO LEAKS WERE NOTICED ANYWHERE ON THE DELIVERY SYSTEM OR SYRINGE. DURING THE EVENT, THE ALTERNATE DETACHMENT ZONE WAS UTILIZED TO DETACH THE COIL. THE SAME SYRINGE WAS NOT UTILIZED WITH OTHER PRODUCTS. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE, COIL OR DELIVERY SYSTEM, AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE VESSEL WAS NOT CALCIFIED AND MODERATELY TORTUOUS. 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 15217441

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE.