BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 3070300 · Received April 22, 2013

    Report

    Report Number
    9616099-2013-00239
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A PROCEDURE, AN OPTEASE VENA CAVA FILTER WAS UNABLE TO BE DEPLOYED. UPON INSPECTION, IT WAS FOUND THAT THE FILTER STRUT WAS PROTRUDING THROUGH THE SHEATH. IT WAS NOTED THAT THE EVENT REQUIRED INTERVENTION. NO OTHER INFORMATION HAS BEEN PROVIDED. MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. 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 LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT, HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A PROCEDURE, AN OPTEASE VENA CAVA FILTER WAS UNABLE TO BE DEPLOYED. UPON INSPECTION, IT WAS FOUND THAT FILTER STRUT WAS PROTRUDING THROUGH THE SHEATH. IT WAS NOTED THAT EVENT REQUIRED INTERVENTION. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171602 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1