BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 3203138 · Received July 2, 2013

    Report

    Report Number
    9616099-2013-00420
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE OF AN OPTEASE VENA CAVA FILTER IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY CROSSING TORTUOUS AND STENOTIC AREAS IN THE LEFT COMMON ILIAC VEIN, DISTAL TO THE DELIVERY SITE IN ATTEMPTS TO REACH THE VENA CAVA FOR FILTER PLACEMENT. IT WAS ORIGINALLY REPORTED THAT PART OF THE FILTER DEPLOYED FROM THE HOUSING AT THIS POINT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BARBS OF THE FILTER POKED THRU THE SIDE OF THE SHEATH. THE EVENT OCCURRED DURING USE IN THE PATIENT. THE SHEATH WAS NOT KINKED WHEN TRYING TO NEGOTIATE THE DEVICE THROUGH THE VESSEL. NO EXCESSIVE FORCE WAS USED TO ADVANCE THE FILTER THROUGH THE DELIVERY SHEATH OR VESSEL. THERE WAS NO DAMAGE TO THE FILTER CARTRIDGE. THE PROCEDURE WAS ABORTED AND THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED FROM PATIENT. THE PATIENT IS A (B)(6) OLD MALE. THE PATIENT HAS A HISTORY OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM AND COULD NOT BE ANTICOAGULATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. UPON RETURN OF THE PRODUCT FOR EVALUATION AND TESTING IT WAS NOTED THAT THE DISTAL END OF THE SHEATH WAS DETACHED AND NOT INCLUDED. ADDITIONAL INVESTIGATION REVEALED THE USER DID NOT NOTICE ANY PROBLEM WITH THE SHEATH OTHER THAN THE FILTER BARBS POKED THROUGH THE SHEATH. ONE NON STERILE 6FR SHEATH INTRODUCER, A NON STERILE OBTURATOR, A NON STERILE STORAGE TUBE AND A NON STERILE FILTER WERE RECEIVED FOR ANALYSIS. THE CSI CANNULA WAS FOUND INCOMPLETE SINCE THE DISTAL END OF THE CANNULA APPEARS TO BE CUT WITH A SHARP OBJECT AT 35.0CM FROM MOLDED HUB AND THE TIP WAS NOT RETURNED. BLOOD RESIDUES WERE FOUND ON THE CANNULA. THE BARB OF THE FILTER THAT WAS INSIDE OF THE CANNULA WAS PROTRUDING THE CANNULA¿S BODY AT 32.2CM FROM MOLDED HUB. PER VISUAL ANALYSIS, NO KINKS OR BENTS CONDITIONS WERE FOUND NEAR TO PROTRUDING CONDITION, AFTER THE FILTER WAS REMOVED FROM THE CANNULA NO ANOMALIES WERE FOUND ON THE FILTER. NO OTHER ISSUES WERE FOUND. THE FILTER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES ON BARBS WERE FOUND. ALSO SEM ANALYSIS WAS PERFORMED TO THE SEPARATED AREA WITH THE FOLLOWING RESULTS: SEM RESULTS SHOW THAT THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE PARTIAL CUTTING, SCRATCHING AND EVIDENCE OF ELONGATION AT THE SURROUNDINGS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. PARTIAL CUTTING AND STRETCHING/PULLING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS. THE FILTER WAS LOADED INTO STORAGE TUBE AND THEN THE FILTER WAS PASSED THROUGH SHEATH AND WAS DEPLOYED SUCCESSFULLY WITH NO RESISTANCE FELT. THE CSI CANNULA OD AND ID WAS MEASURED AGAINST THE DRAWING E7119500 REV. 05 (CURRENT REVISION FOR CATALOG # 466F220A SINCE THE COMPLAINT LOT WAS NOT PROVIDED) AND RESULTS WERE FOUND WITHIN SPECIFICATION. THE DHR REVIEW COULD NOT BE PERFORMED SINCE THE COMPLAIN LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE COMPLAINT REPORTED BY THE CUSTOMER ¿THROMBECTOMY SYSTEMS- FILTER- IMPEDED-PERFORATED SHEATH¿ WAS CONFIRMED, HOWEVER THE CAUSE OF THIS DAMAGED COULD NOT BE DETERMINED DURING THE ANALYSIS. PRODUCT ANALYSIS RESULTS AND DHR REVIEW RESULTS DO NOT SUGGEST THAT FAILURE IS RELATED TO THE MANUFACTURING PROCESS SINCE NO ANOMALIES WERE FOUND ON THE BARBS OF THE FILTER DURING THE MICROSCOPICALLY ANALYSIS AND THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT REPORTED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿CATHETER SHEATH INTRODUCER (CSI) - INSERTION DIFFICULTY¿ COULD NOT BE CONFIRMED DURING THE ANALYSIS; HOWEVER THE OD/ID MEASUREMENT WERE FOUND WITHIN SPECIFICATIONS, SO THIS EVENT IT IS NOT CONSIDERED RELATED TO MANUFACTURING PROCESS. ¿THROMBECTOMY SYSTEMS - BRITE TIP ¿ SEPARATED¿ WAS FOUND DURING ANALYSIS. ACCORDING TO SEM RESULTS THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE PARTIAL CUTTING, SCRATCHING AND EVIDENCE OF ELONGATION AT THE SURROUNDINGS OF THE SEPARATION. CONTROLS ARE IN PLACE TO VERIFY THE TMS CATHETERS FOR DAMAGES ON THE CANNULA, CANNULA TIP AND FILTER; THE PRODUCED CATHETERS ARE INSPECTED BEFORE LEAVING THE FACILITY. 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, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS ARE MOST LIKELY FACTORS CONTRIBUTING TO THE EVENT REPORTED. NEITHER THE INFORMATION PROVIDED NOR THE FAL ANALYSIS RESULTS SUGGEST THAT THE FAILURES ARE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN AND IS REPRESENTED BY (B)(6) 2013 OF THE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DURING USE OF AN OPTEASE VENA CAVA FILTER IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY CROSSING TORTUOUS AND STENOTIC AREAS IN THE LEFT COMMON ILIAC VEIN, DISTAL TO THE DELIVERY SITE IN ATTEMPTS TO REACH THE VENA CAVA FOR FILTER PLACEMENT. IT WAS ORIGINALLY REPORTED THAT PART OF THE FILTER DEPLOYED FROM THE HOUSING AT THIS POINT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BARBS OF THE FILTER POKED THRU THE SIDE OF THE SHEATH. THE EVENT OCCURRED DURING USE IN THE PATIENT. THE SHEATH WAS NOT KINKED WHEN TRYING TO NEGOTIATE THE DEVICE THROUGH THE VESSEL. NO EXCESSIVE FORCE WAS USED TO ADVANCE THE FILTER THROUGH THE DELIVERY SHEATH OR VESSEL. THERE WAS NO DAMAGE TO THE FILTER CARTRIDGE. THE PROCEDURE WAS ABORTED AND THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED FROM PATIENT. THE PATIENT IS A (B)(6) MALE. THE PATIENT HAS A HISTORY OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM AND COULD NOT BE ANTICOAGULATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND PRELIMINARY ANALYSIS STATES THAT ¿DISTAL END DETACHED AND NOT INCLUDED. FILTER PROTRUDING FROM SHEATH AT 3CM FROM END.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301459 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1