BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU

    MDR report key: 2954076 · Received February 11, 2013

    Report

    Report Number
    9616099-2013-00060
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K023116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    CC UPDATED WITH FAL. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING PLACEMENT OF AN OPTEASE RETRIEVABLE INFERIOR VENA CAVA/IVC FILTER, THE PHYSICIAN ENCOUNTERED RESISTANCE/FRICTION DURING ADVANCEMENT THROUGH THE CATHETER SHEATH INTRODUCER/CSI. WHEN FORCE WAS APPLIED, ONE OF THE FILTER ANCHORS RIPPED THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE/IFU. MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND OBTAIN THE PRODUCT FOR EVALUATION WERE UNSUCCESSFUL. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE 6F CSI WAS RECEIVED INSIDE A PLASTIC BAG ALONG WITH A 6F VESSEL DILATOR AND A 6F OBTURATOR. PER VISUAL ANALYSIS NO ANOMALIES WERE FOUND ON THE RECEIVED VESSEL DILATOR AND OBTURATOR. THE BARB OF THE FILTER THAT WAS INSIDE OF THE CANNULA WAS PROTRUDING THE CANNULA'S BODY PER VISUAL ANALYSIS. NO KINKS OR BENTS CONDITIONS WERE FOUND NEAR TO PROTRUDING CONDITION. NO OTHER ISSUES WERE FOUND. THE FILTER WAS RETRIEVED FROM CSI CANNULA WITHOUT RESISTANCE/FRICTION. AFTER THE FILTER WAS REMOVED FROM THE CANNULA NO ANOMALIES WERE FOUND ON THE FILTER. THE FILTER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES ON THE BARBS WERE FOUND. THE CSI CANNULA ID WAS MEASURED AGAINST THE DRAWING AND RESULTS WERE FOUND WITHIN SPECIFICATION. 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 COMPLAINT REPORTED BY THE CUSTOMER "THROMBECTOMY SYSTEMS- FILTER- IMPEDED-PERFORATED SHEATH" WAS CONFIRMED DUE TO THE CONDITION OF THE PRODUCT AS RECEIVED. HOWEVER THE CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINATE DURING PRODUCT ANALYSIS. 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 AND PROCEDURAL FACTORS THAT MAY CONTRIBUTED TO THE EVENT REPORTED. NEITHER THE DHR NOR THE PRODUCT ANALYSIS RESULTS SUGGEST THAT THE REPORTED 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. THEREFORE NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING PLACEMENT OF AN OPTEASE RETRIEVABLE INFERIOR VENA CAVA/IVC FILTER, THE PHYSICIAN ENCOUNTERED RESISTANCE/FRICTION DURING ADVANCEMENT THROUGH THE CATHETER SHEATH INTRODUCER/CSI. WHEN FORCE WAS APPLIED, ONE OF THE FILTER ANCHORS RIPPED THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE/IFU. MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND OBTAIN THE PRODUCT FOR EVALUATION WERE UNSUCCESSFUL. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. 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. REVIEW OF LOT 15653784 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO 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 AND PROCEDURAL FACTORS THAT MAY CONTRIBUTED TO THE EVENT REPORTED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING PLACEMENT OF AN OPTEASE RETRIEVABLE INFERIOR VENA CAVA/IVC FILTER, THE PHYSICIAN ENCOUNTERED RESISTANCE/FRICTION DURING ADVANCEMENT THROUGH THE CATHETER SHEATH INTRODUCER/CSI. WHEN FORCE WAS APPLIED, ONE OF THE FILTER ANCHORS RIPPED THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE/IFU. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59274 OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA 15653784

    Patients

    Seq Age Sex Outcome Treatment
    1