BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1862339 · Received October 8, 2010

    Report

    Report Number
    1058196-2010-00286
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT WITH THE FOURTH COIL, OTHER ORBIT COILS WERE PLACED IN THE TARGET LESION, THE COIL ((B)(4), COMPLAINT PRODUCT 1) WAS DELIVERED IN THE MICROCATHETER ((B)(4), COMPLAINT PRODUCT 2), BUT IT WAS STUCK AND STOPPED ADVANCING. THE COIL WAS REMOVED FROM THE PATIENT AND CHANGED TO OTHER NEW ORBIT COIL ((B)(4), COMPLAINT PRODUCT 3). THE OTHER COIL WAS STUCK IN THE MICROCATHETER AND STOPPED ADVANCING AGAIN. THE COIL WAS REMOVED FROM THE PATIENT AND THE MICROCATHETER WAS CHANGED TO OTHER NEW MICROCATHETER ((B)(4), COMPLAINT PRODUCT 3), THEN THE OTHER COIL WAS ADVANCED IN THE MC WITHOUT ANY DIFFICULTY AND THE PROCEDURE WAS PRECEDED CONTINUOUSLY. THE PROCEDURE WAS COIL EMBOLIZATION FOR INNOMINATE ARTERY (PRIOR TO THORACIC ENDOVASCULAR STENT GRAFT). ACCESS SITE WAS RIGHT CAROTID ARTERY. THE TARGET VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. THE MC WAS NOT RE-SHAPED PRIOR TO USE, AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. DURING PLACEMENT OF THE COIL, NO RESISTANCE OCCURRED DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM, OR DURING ADVANCING AFTER REPOSITIONING. THE 3RD MICROCATHETER WAS ADDED BECAUSE THE COIL WAS STUCK. NO BALLOON REMODELING PRODUCT WAS UTILIZED FOR THE PROCEDURE. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, NO RESISTANCE OCCURRED AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND WITH THE EXCEPTION OF THE 4TH COIL, THE COILS WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE PART OF A COIL WAS RECEIVED TANGLE INSIDE A (B)(4) BAG. THE RECEIVED COIL PART WAS INSPECTED AND IT WAS FOUND STRETCHED, KINKED AND BROKEN. THE RECEIVED PART OF THE COIL WAS INSPECTED UNDER A MICROSCOPE AND IT WAS OBSERVED ON BOTH BROKEN END OF THE COIL THAT IT WAS APPARENTLY STRETCHED/KINKED BEFORE IT BROKE. 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 UNRAVELED AND BROKEN COIL WAS CONFIRMED. WITH ANALYSIS OF THE RETURNED SECTION OF COIL, NO CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE; HOWEVER, IT APPEARS THAT IT WAS STRETCHED PRIOR TO BREAKING. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY AND THE RECORDS INDICATE THAT THE PRODUCT MEETS SPECIFICATION PRIOR TO SHIPMENT. ALTHOUGH IT CANNOT BE CONFIRMED, WITH REVIEW OF THE REPORTED PROCEDURAL INFORMATION, IT APPEARS THAT AFTER PERFORMING THE DETACHMENT STEPS, THE DELIVERY SYSTEM MAY HAVE BEEN WITHDRAWN WITHOUT THE COIL HAVING BEEN DETACHED. THIS PROCEDURAL FACTOR MAY HAVE CONTRIBUTED TO THE COIL STRETCHING FOLLOWED BY BREAKING RESULTING IN PROTRUSION OF THE COIL FROM THE INTENDED TARGET SITE. THE INSTRUCTIONS FOR USE OUTLINES THAT AFTER FOLLOWING THE COIL DETACHMENT STEPS A RAPIDLY DECREASING PRESSURE INDICATES THAT THE EMBOLIC COIL HAS BEEN DETACHED. HOWEVER, EMBOLIC COIL DETACHMENT MUST BE CONFIRMED UNDER FLUOROSCOPY. EMBOLIC COIL DETACHMENT MUST BE CONFIRMED UNDER FLUOROSCOPY BY RELEASING THE SECOND RHV AND SLOWLY RETRACTING THE DELIVERY TUBE ENSURING THAT THE EMBOLIC COIL IS NOT BEING RETRACTED INTO THE TIP OF THE INFUSION CATHETER AND THAT THE DELIVERY TUBE MARKER BANDS MOVE AWAY FROM THE EMBOLIC COIL WITHOUT RESISTANCE. IT IS OUTLINED THAT IF EMBOLIC COIL DETACHMENT IS NOT CONFIRMED, PROCEED TO THE ALTERNATIVE DETACHMENT METHOD. NO CONCLUSION CAN BE MADE WITH ANALYSIS OF THE RETURNED SECTION OF THE COIL; HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT DURING COIL EMBOLIZATION PROCEDURE, THE ORBIT COIL ((B)(4), LOT#:15032700-PRODUCT 4) WAS DELIVERED TO THE TARGET LESION, AND THE COIL WAS DETACHED. WHEN THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM, HE NOTICED THE COIL BECAME STRETCHED (UNRAVELED). THE COIL WAS ATTEMPTED TO BE REMOVED FROM THE PATIENT, THE EMBOLIC COIL WAS SEPARATED IN THE MIDDLE OF THE SELECT LP-ES (MC) MICROCATHETER. THE PROXIMAL PART OF THE EMBOLIC COIL WAS REMOVED FROM THE PATIENT BUT THE DISTAL PART OF THE EMBOLIC COIL REMAINED IN THE BODY. THE SEPARATED COIL WAS ALMOST INSERTED IN THE TARGET ANEURYSM SUCCESSFULLY BY USING THE GUIDING CATHETER (KMP, COOK) AND A COVERED STENT (DETAIL UNKNOWN) WAS PLACED FROM RIGHT CAROTID ARTERY TO SUBCLAVIAN ARTERY TO COVER THE UNRAVELED PART OF THE COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TIME OF SURGERY WAS EXTENDED BY ABOUT 60 MINUTES. PRIOR TO THE EVENT, SEVERAL ORBIT COILS WERE PLACED IN THE TARGET LESION, THE COIL ((B)(4), COMPLAINT PRODUCT 1) WAS DELIVERED IN THE SELECT LP-ES (MC) MICROCATHETER ((B)(4), -PRODUCT 2), BUT IT WAS STUCK AND STOPPED ADVANCING. THE COIL WAS REMOVED FROM THE PATIENT AND CHANGED TO OTHER NEW ORBIT COIL ((B)(4)-PRODUCT 3). THE OTHER COIL WAS STUCK IN THE MICROCATHETER AND STOPPED ADVANCING AGAIN. THE COIL WAS REMOVED FROM THE PATIENT AND THE MICROCATHETER WAS CHANGED TO OTHER NEW SELECT LP-ES MICROCATHETER ((B)(4)-PRODUCT 3), THEN THE OTHER COIL WAS ADVANCED IN THE MC WITHOUT ANY DIFFICULTY AND THE PROCEDURE CONTINUE.

    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. 15032700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SLELET PLUS MICROCATHETER, SNARE DEVICE.