BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 3024185 · Received March 27, 2013

    Report

    Report Number
    1058196-2013-00082
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 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

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL (B)(4) STRETCHED DURING RETRIEVAL FROM THE ANEURYSM, AND AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICE AND SAME LIKE PRODUCT TO PLACE OTHER COILS IN THE ANEURYSM. DURING PLACEMENT, NO ADDITIONAL MANIPULATION AND TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, AND DURING PLACEMENT, 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 NON-CODMAN MICROCATHETER, AND THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER. THE MICROCATHETER WAS RE-SHAPED WITH THE SHAPING MANDREL USED, STEAM, AND WITHOUT ANY DAMAGES. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS. A NON-STERILE ORBIT MINI COMPLEX FILL 2X2 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND KINKS WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED PARTIALLY ZIPPED AND NO DAMAGES WERE NOTED ON IT. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED/KINKED. 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 STRETCHED COIL WAS CONFIRMED. THE INSTRUCTIONS FOR USE PRECAUTIONS THAT IF EMBOLIC COIL REPOSITIONING IS REQUIRED IN THE VASCULATURE, TAKE SPECIAL CARE UNDER FLUOROSCOPY TO VERIFY THAT A ONE-TO-ONE RELATIONSHIP EXISTS BETWEEN THE DELIVERY TUBE AND THE EMBOLIC COIL DURING RETRACTION. ALTHOUGH NO DEFINITIVE ROOT CAUSE CONCLUSION CAN BE MADE, IT IS POSSIBLE THAT PROCEDURAL FACTORS ALONG WITH VESSEL/LESION CHARACTERISTICS CONTRIBUTED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) STRETCHED DURING RETRIEVAL FROM THE ANEURYSM, AND AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICE AND SAME LIKE PRODUCT TO PLACE OTHER COILS IN THE ANEURYSM. DURING PLACEMENT, NO ADDITIONAL MANIPULATION AND TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, AND DURING PLACEMENT, 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 NON-CODMAN MICROCATHETER, AND THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER. THE MICROCATHETER WAS RE-SHAPED WITH THE SHAPING MANDREL USED, STEAM, AND WITHOUT ANY DAMAGES. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126662 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15576556

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER