BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1843194 · Received September 23, 2010

    Report

    Report Number
    1058196-2010-00272
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN EMBOLIZATION PROCEDURE TO TREAT THE DISTAL CAROTID BIFURCATION ANEURYSM WITH COMMUNICATING ARTERY AFTER PLACING TWO COILS, THE THIRD COIL "RATTLED OFF" AND COULD NOT BE PLACED. AN ANGIOTECH SNARE WAS USED TO RETRIEVE THE COIL. THE EVENT OCCURRED DURING THE SECOND TIME OF REPOSITIONING/RETRIEVING THE COIL. NO FURTHER INFORMATION HAS BEEN PROVIDED IN RESPONSE TO MULTIPLE INVESTIGATIVE EFFORTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH FINAL LOT 13467548 AND COIL SUBASSEMBLY LOT 13422669 AND 13422670 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13467548 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS. BASED ON THE REPORT THAT AFTER THE COIL "RATTLED OFF" THE COIL WAS SNARED, IT APPEARS THAT THE COIL MAY HAVE PREMATURELY DETACHED DURING REPOSITIONING IN THE ANEURYSM. THE INSTRUCTIONS FOR USE OUTLINES THAT IF EMBOLIC COIL REPOSITIONING IS REQUIRED IN THE VASCULATURE, TAKE SPECIAL CARE UNDER FLUOROSCOPY TO VERIFY THAT A ONE-TO-ONE RELATIONSHIP EXISTS BETWEEN THE DELIVERY TUBE AND THE EMBOLIC COIL DURING RETRACTION. OTHERWISE THE EMBOLIC COIL MAY HAVE BEEN STRETCHED, WHICH COULD LEAD TO PREMATURE DETACHMENT OR COIL FRACTURE. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT THE RETURN OF THE DEVICE, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED EVENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY RELATED MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MICROCATHETER & SNARE DEVICEADDITIONAL INFORMAITON WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING AN EMBOLIZATION PROCEDURE TO TREAT THE DISTAL CAROTID BIFURCATION ANEURYSM WITH COMMUNICATING ARTERY AFTER PLACING TWO COILS, THE THIRD COIL "RATTLED OFF" AND COULD NOT BE PLACED. AN ANGIOTECH SNARE WAS USED TO RETRIEVE THE COIL. THE EVENT OCCURRED DURING THE SECOND TIME OF REPOSITIONING/RETRIEVING THE COIL. NO FURTHER INFORMATION HAS BEEN PROVIDED IN RESPONSE TO MULTIPLE INVESTIGATIVE EFFORTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH FINAL LOT 13467548 AND COIL SUBASSEMBLY LOT 13422669 AND 13422670 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13467548 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST AS PER 637FM002 REV 15. ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED IN A PLASTIC BAG, SOME BENDS WERE FOUND ALONG THE HYPOTUBE AND THE EMBOLIC COIL WAS FOUND ALREADY SEPARATED AND DAMAGED (KINKED AND UNRAVELED/STRETCHED). NO OTHER ANOMALIES WERE NOTED. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE THE INTRODUCER. THE EMBOLIC COIL WAS INSPECTED UNDER THE MICROSCOPE AND DAMAGES WERE CONFIRMED, IT WAS KINKED, UNRAVELED/STRETCHED AND IT HAS RESIDUES OF DRIED BLOOD. GRIPPER WAS ALSO OBSERVED UNDER THE MICROSCOPE AND RESIDUES OF DRIED BLOOD WERE FOUND. NO OTHER ANOMALIES WERE FOUND. WHILE INSPECTING THE GRIPPER IT WAS NOTED THAT THE HEAD PIECE AND SOME LOOPS FROM EMBOLIC COIL WERE STILL ATTACHED TO THE GRIPPER. THE PRESENCE OF THESE LOOPS INDICATES THAT THE COIL WAS BROKEN AND THAT THERE WAS A GOOD ADHERENCE BETWEEN THE HEAD PIECE AND EMBOLIC COIL. 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. WITH ANALYSIS OF THE RETURNED DEVICE, IT WAS CONFIRMED THAT THE COIL WAS BROKEN WITHOUT PREMATURE DETACHMENT FROM THE GRIPPER. BASED ON THE CONDITION OF THE RETURNED DEVICE IT IS APPARENT THAT EXCESSIVE FORCE WAS APPLIED TO THE EMBOLIC COIL. BASED ON THE ANALYSIS THE CIRCUMSTANCES OF WHEN AND HOW THIS OCCURRED CANNOT BE DETERMINED; HOWEVER, BASED ON THE REPORT THAT IT OCCURRED DURING REPOSITIONING/RETRIEVING OF THE COIL, IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED. THE INSTRUCTIONS FOR USE CAUTIONS TO NEVER WITHDRAW OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF THE RESISTANCE UNDER FLUOROSCOPY. THESE MANIPULATIONS OF THE DELIVERY TUBE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. IT FURTHER PRECAUTIONS THAT IF EMBOLIC COIL REPOSITIONING IS REQUIRED IN THE VASCULATURE, TAKE SPECIAL CARE UNDER FLUOROSCOPY TO VERIFY THAT A ONE-TO-ONE RELATIONSHIP EXISTS BETWEEN THE DELIVERY TUBE AND THE EMBOLIC COIL DURING RETRACTION. OTHERWISE THE EMBOLIC COIL MAY HAVE BEEN STRETCHED, WHICH COULD LEAD TO PREMATURE DETACHMENT OR COIL FRACTURE. IF A ONE-TO-ONE RELATIONSHIP DOES NOT EXIST, THE INFUSION CATHETER AND THE DETACHABLE COIL SHOULD BE REMOVED AS AN ASSEMBLY AND REPLACED. WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL FACTORS ADDRESSED IN THE IFU MAY HAVE CONTRIBUTED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE TO TREAT THE CAROTID BIFURCATION ANEURYSM WITH COMMUNICATING ARTERY AND DISTAL CAROTID, TWO COILS WERE DETACHED IN THE ANEURYSM, BUT DURING THE REPOSITIONING/RETRIEVAL FOR THE SECOND TIME, THE THIRD COIL (ORBIT) RATTLED OFF, AND COULD NOT BE PLACED INTO THE MICROCATHETER, THEY HAD TO USE A LOOP ANGIOTECH SNARE DEVICE TO COLLECT THIS COIL.

    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. 13467548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention