BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1161453 · Received September 10, 2008

    Report

    Report Number
    1058196-2008-00220
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE SALES-REP THAT THE DELIVERY WIRE OF THE TRUFILL DCS ORBIT COIL SYSTEM WAS KINKED WHEN REMOVED FROM THE PACKAGE. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. DURING ANALYSIS, IT WAS NOTED THAT THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND THE COIL WAS STRETCHED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DHR REVIEW PERFORMED INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS. THIS REVIEW REVEALED THAT THE PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ONE NON-STERILE DCS ORBIT WAS RECEIVED. THE HYPOTUBE SHOWED KINKS ON IT. THE EMBOLIC COIL STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED. THE GRIPPER WAS INSPECTED AND SHOWED NO DAMAGES. THE INTRODUCER WAS NOT PROVIDED FOR ANALYSIS. THE CAUSE OF THE STRETCHED CONDITION FOUND IN THE EMBOLIC COIL COULD NOT BE DETERMINED DURING ANALYSIS. THE KINKED FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURES FROM LEAVING THE FACILITY. BASED ON THE VERY LIMITED PROCEDURE INFORMATION, IT CANNOT BE DETERMINED IF HANDLING OF THE DEVICE CONTRIBUTED TO THE REPORTED KINK IN THE TRUFILL DCS ORBIT DELIVERY WIRE. ALTHOUGH IT COULD NOT CONFIRMED, BECAUSE THERE WAS NO REPORT OF A STRETCHED COIL AND THE DEVICE WAS RETURNED WITHOUT THE INTRODUCER THAT PROTECTS THE DELICATE COIL, IT IS LIKELY THAT THE STRETCHED CONDITION FOUND ON THE RETURNED DEVICE OCCURRED AS A RESULT OF POST PROCEDURE HANDLING/PACKAGING. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGEST THAT THE FAILURE IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES-REP THAT THE DELIVERY WIRE WAS KINKED WHEN REMOVED FROM THE PACKAGE. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. DURING ANALYSIS, IT WAS NOTED THAT THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND THE COIL WAS STRETCHED. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL.

    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 13347315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK