BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2190492 · Received August 4, 2011

    Report

    Report Number
    1058196-2011-00397
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION, THE TRUFILL DCS ORBIT MINI COMPLEX FILL 2.5 X 2.5 COIL COULD NOT BE DETACHED. AFTER FIVE (5) FAILED ATTEMPTS, INCLUDING PRESSURIZING TO THE RED ALTERNATIVE DETACHMENT ZONE BEYOND THE GREEN ZONE, THE DEVICE WAS EXCHANGED FOR ANOTHER COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO REPORTED PATIENT INJURY. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM AND WAS FULLY INTACT AFTER REMOVAL FROM THE PATIENT. THE COIL WAS NOT STRETCHED OR SEPARATED UPON INSPECTION AFTER BEING REMOVED FROM THE PATIENT. NO TARGET LESION INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE PRODUCT WAS INSPECTED PRIOR TO USE AND NO PROBLEMS WERE NOTED INCLUDING ANY KINKS OR BENDS. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY REPORTED DIFFICULTY. A DCS SYRINGE WAS USED FOR THE PROCEDURE. THE DCS SYRINGE WAS FILLED WITH SALINE DIRECTLY FROM A STERILE SALINE BAG WITHOUT ADDITIVES OR FROM A DEDICATED SALINE FLUSH LINE. THE DCS SYRINGE USED WITH THIS COIL SUCCESSFULLY DETACHED TWO (2) COILS PRIOR TO THE REPORTED PRODUCT ISSUE AND SUCCESSFULLY DETACHED COILS AFTER THE REPORTED EVENT. THE DCS SYRINGE HAD PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION #3 PRIOR TO THE REPORTED PRODUCT ISSUE. PRIOR TO ATTEMPTING TO DETACH THE 2.5X2.5 COIL IT WAS VERIFIED UNDER FLUOROSCOPY THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER (MC). A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER AND THEY WERE FOUND WITHOUT DAMAGE. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. THE PURGE HOLE WAS FOUND WITHOUT DAMAGE AND NO OBSTRUCTION WAS FOUND ON IT. USING A LAB SAMPLE SYRINGE 635-002, THE TRUFILL DCS SYSTEM WAS PURGING BY PRESSURIZING TO THE BLUE ZONE. AFTER THAT THE EMBOLIC COIL WAS DETACHED WHEN THE NEEDLE OF THE PRESSURE GAUGE WAS ON THE GREEN ZONE. 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 OF THE COIL TO DETACH WITH FUNCTIONAL TESTING WAS NOT CONFIRMED. BASED ON THE REPORTED PROCEDURAL INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER COULD NOT BE DETERMINED. NEITHER THE ANALYSIS NOR THE DEVICE HISTORY RECORDS REVIEW INDICATE THAT THE REPORTED EVENT IS RELATED TO THE MANUFACTURING PROCESS; PROCEDURAL AND HANDLING FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN ATTEMPTED TO RELEASE THE TRUFILL DCS ORBIT MINI COMPLEX FILL 2.5 X 2.5 COIL BUT WAS NOT ABLE TO RELEASE IT. AFTER FIVE (5) FAILED ATTEMPTS, THE PHYSICIAN CHANGED TO ANOTHER COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE PRODUCT WAS INSPECTED PRIOR TO USE AND NO PROBLEMS WERE NOTED INCLUDING ANY KINKS OR BENDS. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY REPORTED DIFFICULTY. A DCS SYRINGE WAS USED FOR THE PROCEDURE. THE DCS SYRINGE WAS FILLED WITH SALINE DIRECTLY FROM A STERILE SALINE BAG WITHOUT ADDITIVES OR FROM A DEDICATED SALINE FLUSH LINE. THE DCS SYRINGE WAS USED TO DEPLOY TWO (2) COILS PRIOR TO THE REPORTED PRODUCT ISSUE WITHOUT ANY REPORTED PROBLEM. THE DCS SYRINGE HAD PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION #3 PRIOR TO THE REPORTED PRODUCT ISSUE. PRIOR TO ATTEMPTING TO DETACH THE COMPLAINT PRODUCT THE PHYSICIAN VERIFIED UNDER FLUOROSCOPY THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER (MC). THE SAME DCS SYRINGE WAS USED SUCCESSFULLY TO DEPLOY ADDITIONAL COILS AFTER THE REPORTED PRODUCT ISSUE. THE DCS SYRINGE WAS TAKEN TO THE RED ALTERNATIVE DETACHMENT ZONE BEYOND THE GREEN ZONE AFTER IT DID NOT DEPLOY THE COMPLAINT PRODUCT IN THE GREEN ZONE. THE DCS SYRINGE DID NOT PRESSURIZE AS INTENDED. THE COIL/COMPLAINT PRODUCT WAS REMOVED FROM THE PATIENT WHILE ATTACHED TO THE DELIVERY SYSTEM AND WAS FULLY INTACT. THE COIL WAS NOT STRETCHED OR SEPARATED UPON INSPECTION AFTER BEING REMOVED FROM THE PATIENT. NO TARGET LESION INFORMATION WAS PROVIDED.

    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 15142580

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE