BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2180622 · Received July 27, 2011

    Report

    Report Number
    1058196-2011-00389
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 30, 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 REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION OF A POSTERIOR COMMUNICATION (PCOM) ANEURYSM, THE PHYSICIAN NOTED UNDER X-RAY THAT THE TRUFILL DCS ORBIT RDFL COMPLEX MINI COIL WAS STRETCHED. THE PRODUCT WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE SIDE WALL ANEURYSM WAS 4X4MM. NECK RE-MODELING WAS NOT USED. AN EV3 MICROCATHETER (MC) WAS USED FOR THE PROCEDURE. THE MC WAS RE-SHAPED USING A MANDREL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED TO THE MC AT ALL TIMES. THERE WAS NO REPORTED RESISTANCE/FRICTION DURING ADVANCEMENT BETWEEN THE ORBIT COIL AND THE MC. THE COIL WAS NOT USED LIKE A GUIDEWIRE TO REPOSITION THE MC. PRIOR TO THIS, NO OTHER COILS HAD BEEN ADVANCED THROUGH THE MC. THERE WERE NO KINKS/BENDS, OR ANY PRODUCT ISSUE NOTED WITH THE MC USED FOR THE PROCEDURE. THE PRODUCT WAS RETURNED FOR INSPECTION. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DEVICE WAS INSPECTED AND KINKS WERE NOTED ALONG OF THE HYPOTUBE. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGED. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED WITH RESIDUES OF DRY BLOOD. THE COIL WAS STILL ATTACHED TO THE GRIPPER. SOME WAVES WERE NOTED ON THE DEVICE; HOWEVER THESE APPEAR TO HAVE OCCURRED DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE THROUGH THE INTRODUCER TUBE SINCE THE DRY BLOOD DID NOT ALLOW ADVANCING THE DEVICE OUT OF INTRODUCER. THE GRIPPER WAS FOUND WITHOUT DAMAGE AND THE EMBOLIC COIL WAS FOUND STRETCHED AND RESIDUES OF DRY BLOOD COULD BE OBSERVED ON THE DISTAL END. 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 STRETCHED COIL WAS CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICE. THE CAUSE OF THE KINKS FOUND ON THE DEVICE AND THE STRETCHED CONDITION OF THE EMBOLIC COIL CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF FAILURES FROM LEAVING THE FACILITY. BASED ON THE AVAILABLE PROCEDURAL INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED EVENT. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    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.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION OF A POSTERIOR COMMUNICATION (PCOM) ANEURYSM, THE PHYSICIAN NOTED THAT THE TRUFILL DCS ORBIT RDFL COMPLEX MINI COIL WAS STRETCHED UNDER X-RAY. THE PHYSICIAN SUCCESSFULLY REMOVED THE PRODUCT FROM THE PATIENT AND USED ANOTHER COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE ANEURYSM WAS REPORTED TO BE: A SIDEWALL ANEURYSM, AND 4X4 MM. NECK RE-MODELING WAS NOT USED. AN EV3 MICROCATHETER (MC) WAS USED FOR THE PROCEDURE. THE MC WAS RE-SHAPED USING A MANDREL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED TO THE MC AT ALL TIMES. THERE WAS NO REPORTED RESISTANCE/FRICTION DURING ADVANCEMENT BETWEEN THE COMPLAINT PRODUCT AND THE MC. THE COMPLAINT PRODUCT/COIL WAS THE FIRST ONE USED FOR THE PROCEDURE-ADVANCED THROUGH THE MC PRIOR TO THE COMPLAINT PRODUCT. THERE WERE NO KINKS/BENDS, OR ANY PRODUCT ISSUE NOTED WITH THE MC USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15236984

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR EV3 MICROCATHETER