BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1923689 · Received December 14, 2010

    Report

    Report Number
    1058196-2010-00377
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    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

    DURING PREP, A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL AND PREP THE SYRINGE, AND THE SYRINGE WAS TAKING TO THE BLUE ZONE. DURING THE PREP, THE BLUE ZONE WAS NOT EXCEEDED. PRIOR TO THIS COIL, ONE# 3 WAS NOT EXCEEDED AT ANY TIME, NOR THE ALTERNATE ZONE (RED) EXCEEDED. AFTER THE COIL DID NOT DETACHED, THE ALTERNATIVE DETACHMENT ZONE (RED) WAS UTILIZED TO DETACH THE CO. THE PRODUCT WAS CONNECTED PROPERLY TO THE HUB OF THE COIL DELIVERY SYSTEM, AND THE CONNECTOR WAS CHECKED FOR PROPER SEATING/FITTING ON THE DELIVERY SYSTEM HUB. AFTER DISCONNECTING THE COIL DELIVERY SYSTEM, NO DAMAGED WAS NOTED ON THE SYRINGE. AFTER THE PRODUCT FAILURE OCCURRED, NO DAMAGES WERE NOTED ON THE SYRINGE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE THE 3X6 TRUFILL ORBIT HELICAL FILL COIL COULD NOT BE DETACHED. THE ALTERNATIVE DETACHMENT METHOD WAS ATTEMPTED WITHOUT SUCCESS AND THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH EXCHANGE FOR ANOTHER UNKNOWN COIL. THERE WERE NO DAMAGES NOTED ON THE DELIVERY SYSTEM OR COIL WHEN REMOVED FROM THE PATIENT AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THIS WAS THE FIRST COIL TO BE INSERTED INTO THE 3.2X2.9X2.0MM ANEURYSM. DURING PREP A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL AND PREP THE SYRINGE WHICH HAD NOT BEEN PRESSURIZED ABOVE THE GREEN ZONE PRIOR TO USE WITH THIS COIL. THE SYRINGE WAS CONNECTED PROPERLY TO THE HUB OF THE COIL DELIVERY SYSTEM AND TAKEN ONLY TO THE BLUE PURGE ZONE DURING PREP. THE SYRINGE GAUGE INDICATED PRESSURIZATION BOTH DURING PREP, WHEN TAKEN TO THE GREEN DEPLOYMENT ZONE AND TO THE RED ALTERNATIVE DETACHMENT ZONE. AFTER DISCONNECTING THE COIL DELIVERY SYSTEM, NO DAMAGED WAS NOTED ON THE SYRINGE. AFTER THE PRODUCT FAILURE OCCURRED, NO DAMAGES WERE NOTED ON THE SYRINGE. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS ZIPPED, PART OF THE EMBOLIC COIL AS WELL AS THE SUPPORT COIL WERE INSIDE OF IT. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND NEITHER THE EMBOLIC COIL NOR THE GRIPPER PRESENTED DAMAGES. NO DAMAGES WERE NOTED IN THE SUPPORT COIL. BENDS WERE NOTED IN THE HYPOTUBE. NO OTHER DAMAGES WERE NOTED IN THE DEVICE. EMBOLIC COIL AND GRIPPER WERE INSPECTED UNDER MICROSCOPE AND NO ANOMALIES OR DAMAGES WERE NOTED. USING A LAB SAMPLE SYRINGE (B)(4) THE DEVICE WAS PURGED WHEN THE PRESSURE GAGE WAS IN THE BLUE ZONE; AFTER THAT THE PRESSURE GAGE WAS INCREASE UNTIL THE GREEN ZONE AND AT THIS TIME THE EMBOLIC COIL WAS DETACHED. 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. REVIEW OF LOT 15192180 INDICATES NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED FAILURE OF THE COIL TO DETACH WAS NOT CONFIRMED WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE; THE COIL DETACHED IN THE GREEN DETACHMENT ZONE WITHOUT ANY DIFFICULTIES. THE CAUSE OF THE BENDS NOTED IN THE HYPOTUBE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING THE FACILITY. BASED ON THE AVAILABLE INFORMATION AND THE ANALYSIS, WHICH FOUND NO DISCREPANCY, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED INABILITY TO DETACH THE COIL. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO IMPLANT THE COIL, BUT IT COULD NOT DEPLOY NORMALLY, SO PHYSICIAN CHANGE ANOTHER ONE TO COMPLETE THE SURGERY. THE COIL WAS ABLE TO MAKE INTO THE ANEURYSM, BUT IT WAS UNABLE TO DETACH THE COIL. THIS WAS THE FIRST COIL THAT WAS INSERTED IN THE ANEURYSM. AFTER REMOVAL, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED, FRACTURE, ETC) OR COIL (KINK, BEND, UNRAVELED, STRETCHED, FRACTURE, SEPARATED, ETC), AND AFTER THE EVENT, THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE ANEURYSM SIZE WAS 3.2X2.9X2.0MM. THE DCS SYRINGE PRESSURE GAUGE INDICATOR MOVED INITIALLY WHEN PRESSURE WAS APPLIED TO THE BLUE ZONE, AND THE INDICATOR DID NOT GET STUCK AT THE GREEN ZONE. ONCE THE SYRINGE WAS DISCONNECTED, THE INDICATOR DID NOT MOVE.

    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 15001080

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SYRINGE