BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2993528 · Received March 7, 2013

    Report

    Report Number
    1058196-2013-00065
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE ORBIT COILS ((B)(4)) STRETCHED DURING POSITIONING INTO THE TARGET ANEURYSM. AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICES. DURING POSITIONING, NO ADDITIONAL MANIPULATION OR TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, BUT DURING POSITIONING, THE COIL WAS LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER, AND THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC). THERE WAS NO ADVERSE EVENT, AND THE DEVICES WILL BE RETURNED FOR ANALYSES. A NON-STERILE ORBIT MINI COMPLEX FILL 3.5X5 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND KINKS WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED ZIPPED AND NO DAMAGES WERE NOTED ON IT. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER AND NO DAMAGES WERE NOTED ON THEM. 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. THE REPORTED FAILURE STRETCHED COIL WAS NOT CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF FAILURES FROM LEAVING THE FACILITY. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2013-00065 AND 1058196-2013-00066.

    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 15581886 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2013-00065 AND 1058196-2013-00066.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ORBIT COILS (637MF3505/15581886AND 638CF0615/15665270) STRETCHED DURING POSITIONING INTO THE TARGET ANEURYSM. AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICES. DURING POSITIONING, NO ADDITIONAL MANIPULATION OR TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, BUT DURING POSITIONING, THE COIL WAS LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER, AND THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC). THERE WAS NO ADVERSE EVENT, AND THE DEVICES WILL BE RETURNED FOR ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97431 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15581886

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER