BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 2962397 · Received February 14, 2013

    Report

    Report Number
    9616099-2013-00071
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING IMPLANTATION OF A 55 CM. OPTEASE INFERIOR VENA CAVA/IVC FILTER, IT WAS REPORTED THAT THE FILTER BECAME STUCK INSIDE THE CATHETER SHEATH INTRODUCER. THE PHYSICIAN PUSHED STRONGLY TO ADVANCE THE FILTER BUT WAS NOT SUCCESSFUL. THE OPTEASE FILTER WAS REMOVED WITHOUT BEING DEPLOYED AND A TRACE OF THE FILTER WAS NOTED INSIDE THE SHEATH. ANOTHER FILTER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY VIA THE RIGHT FEMORAL VEIN. THERE WAS NO REPORTED PATIENT INJURY. THE IVC WAS REPORTED TO BE SLIGHTLY TORTUOUS AND NOT CALCIFIED. THE INDICATION FOR THE PROCEDURE WAS DEEP VEIN THROMBOSIS/DVT. THE APPROACH WAS MADE FROM THE LEFT FEMORAL VEIN WITH A SHEATH INTRODUCER (ACCESSORY FOR OPTEASE). THE FILTER WAS INSERTED INTO THE SHEATH BY THE OBTURATOR, BUT THE FILTER WAS STUCK INSIDE THE SHEATH INTRODUCER. THE PHYSICIAN PUSHED THE OBTURATOR STRONGLY AND PUSHED THE SHEATH INTRODUCER AS A UNIT, BUT THE FILTER COULD NOT BE ADVANCED FURTHER. BOTH PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. BOTH PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE IFU AND NO PROBLEMS WERE NOTED DURING PREPARATION. THE SHEATH WAS FLUSHED PROPERLY. THERE WAS NO DIFFICULTY REPORTED WHILE ACCESSING THE SHEATH THROUGH THE VESSEL AND THERE WAS NO KINK REPORTED, BUT THERE WAS A TRACE OF THE FILTER OBSERVED INSIDE THE SHEATH. IT WAS UNKNOWN IF THE SAME SHEATH WAS USED WITH THE SECOND FILTER TO COMPLETE THE PROCEDURE OR THE NEW SHEATH OF THE NEW PRODUCT WAS USED INSTEAD. ONE NON-STERILE 6FR SHEATH INTRODUCER, ONE NON-STERILE 6FR OBTURATOR, ONE NON-STERILE 6FR VESSEL DILATOR AND ONE NON-STERILE FILTER INSIDE ITS STORAGE CARTRIDGE WERE RECEIVED. NO VISUAL ANOMALIES WERE FOUND ON THE CANNULA, VESSEL DILATOR OR THE OBTURATOR. THE FILTER WAS RECEIVED INSIDE THE STORAGE CARTRIDGE(NON DEPLOYED) WITHOUT VISUAL ANOMALIES. THE RETURNED FILTER WAS DEPLOYED USING THE INVOLVED UNITS (CANNULA AND OBTURATOR). THE DEPLOYMENT WAS PERFORMED WITHOUT ANY TYPE OF ANOMALIES. REVIEW OF LOT 15711673 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE IFU INSTRUCTS TO SLOWLY ADVANCE THE FILTER INTO THE SHEATH INTRODUCER BY ADVANCING THE OBTURATOR THROUGH THE END OF THE STORAGE TUBE UNTIL THE FILTER IS POSITIONED WELL INTO THE CANNULA OF THE SHEATH INTRODUCER. CONTINUE TO ADVANCE THE FILTER UNTIL THE MARKER ON THE OBTURATOR IS POSITIONED AT THE SHEATH INTRODUCER HEMOSTASIS VALVE. THIS INDICATES THAT THE FILTER IS AT THE DISTAL TIP OF THE SHEATH INTRODUCER BUT STILL FULLY WITHIN THE SHEATH INTRODUCER. NOTE: IF FILTER ADVANCEMENT IS PROBLEMATIC WHEN USING A TORTUOUS VESSEL APPROACH, STOP FILTER ADVANCEMENT PRIOR TO THE CURVE. ADVANCE THE SHEATH INTRODUCER TO NEGOTIATE THE CURVE, THEN CONTINUE TO ADVANCE THE FILTER. WHEN FILTER IS PASSING AN ACUTE BEND INSIDE THE SHEATH DUE TO VESSEL TORTUOSITY, THE BARBS IN THE FILTER HAVE THE POTENTIAL TO STICK OUT RESULTING IN RESISTANCE/FRICTION ADVANCING THE FILTER THROUGH THE SHEATH. IF FORCE IS APPLIED, THE BARBS HAVE THE POTENTIAL TO PERFORATE THE SHEATH. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (TORTUOUSITY) AND PROCEDURAL FACTORS THAT MAY CONTRIBUTED TO THE EVENT REPORTED. THE FILTER IMPEDED REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING ANALYSIS SINCE NO ANOMALIES WERE FOUND DURING THE INVESTIGATION OF THE RETURNED UNITS. NEITHER THE DHR NOR THE PRODUCT ANALYSIS INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    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 IMPLANTATION OF A 55 CM. OPTEASE INFERIOR VENA CAVA/IVC FILTER FOR FEMORAL DELIVERY ONLY, THE FILTER BECAME STUCK INSIDE THE CATHETER SHEATH INTRODUCER. THE PHYSICIAN PUSHED STRONGLY TO ADVANCE THE FILTER BUT WAS NOT SUCCESSFUL. THE OPTEASE FILTER WAS REMOVED WITHOUT BEING DEPLOYED AND A TRACE OF THE FILTER WAS NOTED INSIDE THE SHEATH. ANOTHER FILTER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY VIA THE RIGHT FEMORAL VEIN. THERE WAS NO REPORTED PATIENT INJURY. THE IVC WAS REPORTED TO BE SLIGHTLY TORTUOUS AND NOT CALCIFIED. THE INDICATION FOR THE PROCEDURE WAS DEEP VEIN THROMBOSIS/DVT. THE APPROACH WAS MADE FROM THE LEFT FEMORAL VEIN WITH A SHEATH INTRODUCER (ACCESSORY FOR OPTEASE). THE FILTER WAS INSERTED INTO THE SHEATH BY THE OBTURATOR. THEN, THE OPTEASE FILTER (COMPLAINT PRODUCT) WAS INSERTED IN THE SHEATH INTRODUCER BY THE OBTURATOR, BUT THE FILTER WAS STUCK INSIDE THE SHEATH INTRODUCER. THE PHYSICIAN PUSHED THE OBTURATOR STRONGLY AND PUSHED THE SHEATH INTRODUCER AS A UNIT, BUT THE FILTER COULD NOT BE ADVANCED FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64673 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA 15711673

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR