BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1971722 · Received January 27, 2011

    Report

    Report Number
    1058196-2011-00042
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIDEWALL ANEURYSM WAS THE JUNCTION OF THE RIGHT (ICA) INTERNAL CAROTID ARTERY AND (PCOM) POSTERIOR COMMUNICATING ARTERY AND HAD A WIDE NECK (4MM), SIZE WAS 6X6MM IN DIAMETER, AND THE NECK TO SAC RATION WAS 1:1.5. MEDICATION CONSISTED OF NIMODIPINE , MANNITOL, AND ANTIBIOTIC- MONOCEF. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS GRADE III ON VENTILATOR, BEFORE THE PROCEDURE AND WAS ELECTIVELY VENTILATED FOR 48 HRS. THE ANEURYSM WAS OBLITERATED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE STENT, THE ORBIT 3D 3 MM X 4 CM COIL STRETCHED DURING RETRIEVAL FOR REPOSITIONING IN THE ANEURYSM SAC. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES, AND A BALLOON REMODELING DEVICE WAS NOT UTILIZED. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT OF THE COIL, THERE WAS NO RESISTANCE DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM, AND ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE, SINCE IT WAS NOT DAMAGED. THE SIDEWALL ANEURYSM WAS THE JUNCTION OF THE RIGHT (ICA) INTERNAL CAROTID ARTERY AND POSTERIOR COMMUNICATING ARTERY (PCOM) AND HAD A WIDE NECK (4 MM), SIZE WAS 6X6 MM IN DIAMETER, AND THE NECK TO SAC RATION WAS 1:1.5. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. HYPOTUBE PRESENTED SOME BENDS BUT THESE APPEAR TO HAVE OCCURRED DURING THE HANDLING OF THE UNIT FOR RETURN. INTRODUCER WAS PROPERLY ZIPPED WITHOUT DAMAGES. SUPPORT COIL AND EMBOLIC COIL WERE INSIDE OF INTRODUCER. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED AT PROXIMAL SIDE. NO OTHER ANOMALIES WERE NOTED IN THE DEVICE. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND. REVIEW OF LOT 15166503 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED STRETCHING OF THE COIL WAS CONFIRMED. WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORD REVIEW INDICATE ANY RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE FACILITY. ALTHOUGH BASED ON THE AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING ROOT CAUSE, PROCEDURAL FACTORS APPEAR TO BE CONTRIBUTED IN THE FAILURE REPORTED BY THE CUSTOMER; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. HYPOTUBE PRESENTED SOME BENDS BUT THESE APPEAR TO OCCUR DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. INTRODUCER WAS PROPERLY ZIPPED WITHOUT DAMAGES. SUPPORT COIL AND EMBOLIC COIL WERE INSIDE OF INTRODUCER. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED AT PROXIMAL SIDE. NO OTHER ANOMALIES WERE NOTED IN THE DEVICE. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND. 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 15166503 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FAILURE REPORTED BY THE CUSTOMER AS "COIL UNRAVELED AND STRETCHED" WAS CONFIRMED. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS DAMAGE COULD BE RELATED TO THE MANUFACTURING PROCESS. PER (B)(6) INVESTIGATION THE CUSTOMER STATE THAT "THE ORBIT 3D 3MM X 4 CM COIL STRETCHED DURING RETRIEVAL FOR REPOSITIONING IN THE ANEURYSM SAC" THIS INDICATES THAT THE EMBOLIC COIL WAS WITHOUT DAMAGES WHEN IT WAS REMOVED FROM THE PACKAGE. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF DAMAGE LEAVING FROM THE FACILITY. PROCEDURAL FACTORS APPEAR TO BE CONTRIBUTED IN THE FAILURE REPORTED BY THE CUSTOMER; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE STENT, THE ORBIT 3D 3MM X 4 CM COIL STRETCHED DURING RETRIEVAL FOR REPOSITIONING IN THE ANEURYSM SAC. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES, AND A BALLOON REMODELING DEVICE WAS NOT UTILIZED. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT OF THE COIL, THERE WAS NO RESISTANCE DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM, AND ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE, SINCE IT WAS NOT DAMAGED.

    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 15166503

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER