BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2243446 · Received September 12, 2011

    Report

    Report Number
    1058196-2011-00437
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 23, 2011
    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 A COIL EMBOLIZATION PROCEDURE, THE ORBIT MINI COMPLEX FILL 3.5X9 COIL ((B)(4)) STRETCHED DURING PLACEMENT IN THE ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. NO ADVERSE OCCURRED DUE TO THE EVENT. AFTER THE EVENT, THE COIL AND DELIVERY SYSTEMS WERE REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE SL10 45 MICROCATHETER (MC) AT ALL TIMES, AND THE SAME MC WAS UTILIZED TO COMPLETE THE PROCEDURE. THE MC WAS NOT RE-SHAPED PRIOR TO USE. NO RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MC OR ANY OTHER TIME, AND NO KINKS WERE NOTED IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO BALLOON OR STENT REMODELING PRODUCT WAS USED DURING THE PROCEDURE. DURING REPOSITIONING, THE COIL WAS LEFT IN THE ANEURYSM, WHILE THE MC WAS REPOSITIONED. THE INSTRUCTIONS FOR USE PRECAUTIONS THAT REPOSITIONING THE INFUSION CATHETER WHILE THE COIL IS DEPLOYED MAY LEAD TO DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. DURING INSERTION OR ANY OTHER TIME, NO RESISTANCE WAS MET. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCT. NO FURTHER INFORMATION WAS PROVIDED. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE. THE SUPPORT, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE, AND THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPER. 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 CAUSE OF THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINATE. HOWEVER, NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE MANUFACTURING PROCESS; INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURES LEAVING FROM THE FACILITY. THE PROCEDURAL FACTOR OF REPOSITIONING THE MICROCATHETER OVER THE COIL, WHICH IS ADDRESSED IN THE INSTRUCTIONS FOR USE, MAY HAVE CONTRIBUTED. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE. THE SUPPORT, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE, AND THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. 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 FAILURE REPORTED BY THE COSTUMER AS "COIL - UNRAVELED/STRETCHED" WAS CONFIRMED. THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINATE; NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS SINCE INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE PRODUCT WAS RETURNED AND ANALYZED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE ORBIT MINI COMPLEX FILL 3.5X9 COIL (637MF3509/15320727) WAS STRETCHED DURING THE PROCEDURE. THERE WAS NO SERIOUS INJURY REPORTED WITH THE EVENT.

    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 15320727

    Patients

    Seq Age Sex Outcome Treatment
    1