BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1954318 · Received January 10, 2011

    Report

    Report Number
    1058196-2011-00009
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 15, 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

    IT WAS REPORTED THAT AFTER ADJUSTING THE POSITION OF THE THIRD COIL, A 2X4 ORBIT HELICAL FILL COIL, SEVERAL TIMES AT THE UNKNOWN TARGET SITE IT COULD NOT BE WITHDRAWN INTO THE EV3/ECHELON 10 MICROCATHETER FOR REMOVAL. THEREFORE, THE COIL AND THE MICROCATHETER WERE WITHDRAWN AS A UNIT. ANOTHER ECHELON 10 MICROCATHETER AND COIL WERE USED TO COMPLETE THE PROCEDURE WITH ANGIOGRAPHY DEMONSTRATING THAT THE ANEURYSM WAS WELL FILLED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED AT ALL TIMES THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE DURING ADVANCEMENT THROUGH THE MICROCATHETER PRIOR TO POSITIONING IN THE ANEURYSM. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHEN ADJUSTING THE POSITION. IT IS NOT KNOWN IF THE COIL STRETCHED PRIOR TO THE INABILITY TO WITHDRAW IT INTO THE MICROCATHETER. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. PART OF THE INTRODUCER WAS UNZIPPED AND PART OF THE SUPPORT COIL WAS OUT OF IT. SUPPORT COIL PRESENTED BENDS. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND PRESENTED NO DAMAGES. KINKS WERE NOTED IN THE HYPOTUBE. EMBOLIC COIL AND GRIPPER WERE INSPECTED UNDER MICROSCOPE AND NO ONE PRESENTED DAMAGES. INTRODUCER PRESENTED A COMPRESSED SECTION. SUPPORT COIL WAS RECAPTURED INSIDE OF THE INTRODUCER AND THEN WAS TRIED TO ZIP THE INTRODUCER; HOWEVER IT COULD NOT BE COMPLETELY ZIPPED DUE TO THE COMPRESS SECTION NOTED IN THE INTRODUCER. DEVICE WAS INSERTED INSIDE OF A MICROCATHETER CORDIS LAB SAMPLE THAT WAS PREVIOUSLY FLUSHED AND THEN WAS REMOVED WITHOUT ANY DIFFICULTY. 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 15142584 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED WITHDRAWAL OF THE RETURNED DEVICE WAS NOT CONFIRMED WITH FUNCTIONAL TESTING USING A CORDIS LAB SAMPLE MICROCATHETER. IF THE INTRODUCER WAS RE-ENGAGED FOR INTENDED RE-ZIPPING DURING THE ATTEMPTED REMOVAL, IT IS POSSIBLE THE COMPRESSED/KINKED CONDITION MAY HAVE IMPACTED THE EVENT. THE CAUSE OF THE DAMAGES NOTED IN THE HYPOTUBE, INTRODUCER AND SUPPORT COIL COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THESE DO NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS AS THERE WERE NO REPORTED DAMAGES OR DIFFICULTY DURING THE INSERTION OF THE COIL. ADDITIONALLY, INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. THE CAUSE OF THE REPORTED EVENT IS INCONCLUSIVELY AND UNDETERMINED; HOWEVER, PROCEDURAL FACTORS AND THE CONCOMITANT MICROCATHETER MAY HAVE IMPACTED THE EVENT. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE SURGERY, THE PHYSICIAN USED EV3 MICROCATHETER (ECHELON 10) TO POSITION TO THE TARGET. WHEN THE PHYSICIAN PLANNED TO IMPLANT THE THIRD COIL (2X4MM) INTO ANEURYSM AFTER IMPLANTING TWO COILS SUCCESSFULLY, HE ADJUSTED THE POSITION SEVERAL TIMES BUT STILL NOT SATISFACTION, THEN HE DECIDED TO WITHDRAW THE COIL BUT IT COULD NOT BE WITHDRAWN INTO MICROCATHETER, SO THE PHYSICIAN WITHDREW THE MICROCATHETER WITH THE COIL. THEN PHYSICIAN USED NEW MICROCATHETER (ECHELON10) AND CHANGED ANOTHER COIL TO COMPLETE THE SURGERY. THE ANGIOGRAPHY SHOWED THE ANEURYSM WAS FILLED WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 15142584

    Patients

    Seq Age Sex Outcome Treatment
    1