BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1880071 · Received October 22, 2010

    Report

    Report Number
    1058196-2010-00303
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 27, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO USE, THE ORBIT MINI COMPLEX FILL 3.5X7.5 COIL WAS ALREADY DETACHED FROM DELIVERY SYSTEM UPON OPENING OF PACKAGE. THE PRODUCT WAS NEW, AND THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. THE PRODUCT INNER AND OUTER PACKAGE WAS NOT DAMAGED. THE COIL WAS SEEN IN THE INNER POUCH WITHOUT REMOVING THE SYSTEM; THE DELIVERY SYSTEM WAS NOT REMOVED FROM THE PLASTIC LOOP. THE EVENT WAS NOT RELATED TO REMOVAL FROM THE PLASTIC HOOP. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITH REVIEW OF LOT FINAL ASSEMBLY 15104099 AND CORRESPONDING COIL SUBASSEMBLY LOTS 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 AVAILABLE INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED PREMATURE DEPLOYMENT OF THE COIL. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PRIOR TO USE, THE ORBIT MINI COMPLEX FILL 3.5X7.5 COIL WAS ALREADY DETACHED FROM DELIVERY SYSTEM UPON OPENING OF PACKAGE.

    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 15104099

    Patients

    Seq Age Sex Outcome Treatment
    1