BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2120611 · Received June 10, 2011

    Report

    Report Number
    1058196-2011-00287
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER AND THEY WERE FOUND IN TANGLED CONDITION. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE JUST RESIDUES OF DRY BLOOD COULD BE OBSERVED ON THE GRIPPER. THE EMBOLIC COIL WAS FOUND STRETCHED/UNRAVELED/KINKED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE SUPPORT COIL, GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND THEY WERE FOUND IN TANGLED CONDITION; THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE JUST RESIDUES OF DRY BLOOD COULD BE OBSERVED ON THE GRIPPER. THE EMBOLIC COIL WAS FOUND STRETCHED/UNRAVELED/KINKED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. (SEVERAL KINKS AND THE TANGLED CONDITION PRESENTED BY THE EMBOLIC COIL). 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 IMPEDED IN MICRO CATHETER" COULD NOT BE EVALUATED DUE THE CONDITIONS OF THE RECEIVED PRODUCT. THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENT THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE IC-PARACLINOID, AFTER THE FIRST COIL ((B)(4) SOFT 4X8, BOSTON SCIENTIFIC) WAS PLACED IN THE TARGET SITE SUCCESSFULLY, BUT WHEN THE ORBIT MINI COMPLEX FILL 3.5X9 COIL (B)(4) WAS USED AS THE SECOND COIL. WHEN THE COIL WAS ADVANCED IN THE (MC) MICROCATHETER (SL10 STR, BOSTON SCIENTIFIC), IT WAS STUCK AND STOPPED ADVANCING, AFTER THE EVENT THE ENTIRE SYSTEM, COIL AND MC WERE REMOVED AS A UNIT. NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES, AND THE DISTAL TIP WAS NOT RE-SHAPED. AFTER REMOVAL FROM THE PATIENT, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON ANY OF THE DEVICES (COIL DELIVERY SYSTEMS- FRACTURES, SEPARATED, KINKS, BENDS, ETC, DISTAL TIPS -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, COILS-FRACTURE, SEPARATED, STRETCHED, UNRAVELED, KINK, BEND, ETC, AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. ACCESS SITE WAS RIGHT FEMORAL ARTERY. THE VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT INJURY. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER AND THEY WERE FOUND IN TANGLED CONDITION. WITH VISUAL AND MICROSCOPIC EXAMINATION, THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE JUST RESIDUES OF DRY BLOOD COULD BE OBSERVED ON THE GRIPPER. THE EMBOLIC COIL WAS FOUND STRETCHED/UNRAVELED/KINKED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. A FUNCTIONAL TEST TO EVALUATE THE REPORTED INABILITY TO INTRODUCE THE DEVICE THROUGH A MICROCATHETER COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT. (SEVERAL KINKS AND THE TANGLED CONDITION PRESENTED BY THE EMBOLIC COIL). 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 EVENT AND DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THERE IS NO INDICATION THAT THE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS AND DEVICE INTERACTION APPEAR TO HAVE CONTRIBUTED TO THESE DAMAGES. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE FACILITY AND THE OD WAS WITHIN SPECIFICATION. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE IC-PARACLINOID, AFTER THE FIRST COIL (GDC360 SOFT 4X8, BOSTON SCIENTIFIC) WAS PLACED IN THE TARGET SITE SUCCESSFULLY, BUT WHEN THE ORBIT MINI COMPLEX FILL 3.5X9 COIL (637MF3509) WAS USED AS THE SECOND COIL. WHEN THE COIL WAS ADVANCED IN THE (MC) MICROCATHETER (SL10 STR, BOSTON SCIENTIFIC), IT WAS STUCK AND STOPPED ADVANCING, AFTER THE EVENT THE ENTIRE SYSTEM, COIL AND MC WERE REMOVED AS A UNIT. NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES, AND THE DISTAL TIP WAS NOT RE-SHAPED. AFTER REMOVAL FROM THE PATIENT, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON ANY OF THE DEVICES (COIL DELIVERY SYSTEMS- FRACTURES, SEPARATED, KINKS, BENDS, ETC, DISTAL TIPS -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, COILS-FRACTURE, SEPARATED, STRETCHED, UNRAVELED, KINK, BEND, ETC, AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. ACCESS SITE WAS RIGHT FEMORAL ARTERY. THE VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT INJURY.

    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 15227354

    Patients

    Seq Age Sex Outcome Treatment
    1 SL10 STR MICROCATHETER