BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1791981 · Received August 10, 2010

    Report

    Report Number
    1058196-2010-00217
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN NOTED THAT THE COIL WAS STRETCHED BEFORE USE ON THE PATIENT. PRIOR TO OPENING, THE PRODUCT EXTERNAL BOX OR INTERNAL PACKAGES WERE NOT DAMAGED, AND THE PRODUCT WAS STORED, HANDLED AND PREPPED PER LABELING INSTRUCTIONS. IT WAS REPORTED THAT DURING REMOVAL, NOTHING OCCURRED THAT MAY HAVE CAUSED THE REPORTED EVENT, AND THE COIL DID NOT GET HUNG UP ON ANYTHING. THE COIL DELIVERY SYSTEM WAS REMOVED PER LABELING INSTRUCTIONS. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE OR DELIVERY SYSTEM. NO FURTHER INFORMATION WAS AVAILABLE. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE UNIT WAS INSPECTED AND KINKS WERE FOUND IN HYPOTUBE. THE INTRODUCER WAS ZIPPED AND NO DAMAGES WERE FOUND. THE SUPPORT COIL, THE GRIPPER AND THE EMBOLIC COIL WERE INSIDE OF THE INTRODUCER. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND WAS STRETCHED AND KINKED, THE GRIPPER PRESENTED WAVED SECTIONS AT THE PROXIMAL SIDE. ADDITIONALLY RESIDUES OF BLOOD WERE OBSERVED INSIDE OF THE GRIPPER. THE HUB WAS INSPECTED AND NO DAMAGE WAS FOUND. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND STRETCHED SECTIONS AND KINKS IN EMBOLIC COIL, THE WAVES AND THE RESIDUES OF BLOOD FOUND IN THE GRIPPER WERE CONFIRMED. 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 UNRAVELED/STRETCHED CONDITION OF THE COIL WAS CONFIRMED. THE CAUSE OF THE COIL STRETCHED, KINKED AND THE WAVES FOUND IN THE GRIPPER COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THE DEVICE WAS NOT USED IN THE PATIENT; HOWEVER, THIS IS NOT CONSISTENT WITH RESIDUES OF BLOOD FOUND INSIDE OF THE GRIPPER. BASED ON THIS, PROCEDURAL FACTORS/HANDLING OF THE DEVICE MAY HAVE CONTRIBUTED TO THE DAMAGES NOTED ON THE RETURNED DEVICE. THE IFU OUTLINES "DO NOT USE A COIL SYSTEM THAT SHOWS SIGNS OF DAMAGES." NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THESE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF FAILURES FROM LEAVING FROM THE FACILITY. BASED ON THE RECEIVED CONDITION OF THE UNIT, THE CAUSE OF THE COMPLAINT IS INCONCLUSIVE AND UNDETERMINED; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PHYSICIAN NOTED THAT THE COIL WAS STRETCHED BEFORE USED ON THE PATIENT. PRIOR TO OPENING, THE PRODUCT EXTERNAL BOX OR INTERNAL PACKAGES WERE NOT DAMAGE, AND THE PRODUCT WAS STORED, HANDLED AND PREP PER LABELING INSTRUCTIONS. DURING REMOVAL, NOTHING OCCURRED THAT MAY HAVE CAUSED THE REPORTED EVENT, AND THE COIL DID NOT GET HUNG UP ON SOMETHING. THE COIL DELIVERY SYSTEM WAS REMOVED PER LABELING INSTRUCTIONS. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (DISTAL TIP UNRAVELED, STRETCHED, FRACTURE, SEPARATED, ETC) OR DELIVERY SYSTEM. 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 13471524

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR