BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU

    MDR report key: 1833991 · Received September 14, 2010

    Report

    Report Number
    9610978-2010-00177
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    July 24, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K023116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON STERILE OPTEASE RETRIEVAL FILTER WAS RETURNED COILED AND INSIDE A BAG. THE RETURNED PRODUCT INCLUDES THE VESSEL DILATOR, THE OBTURATOR, AND THE CSI WITH THE FILTER. THE VESSEL DILATOR WAS NOTED WITH THE TIP CUT. THE CSI HAS THE FILTER INSIDE AND ONE FILTER'S BARB IS PROTRUDING THRU THE CATHETER. THE CSI (CATHETER) PRESENTS A NEAR SEPARATION AT 18.5CM FROM THE DISTAL TIP AND ALSO IT WAS NOTED A KINK AT 48 CM FROM THE DISTAL TIP AS WELL. THE BARBS WERE REVIEWED UNDER MICROSCOPE AT 25X OF MAGNIFICATION, NO DAMAGE OR ANY ANOMALY WAS NOTED IN THE BARBS. THE FILTER WAS ADVANCED IN THE CSI AND A LITTLE RESISTANCE WAS FELT WHEN THE FILTER PASSED THROUGH THE SEPARATED AREA OF THE CSI, HOWEVER THE FILTER COULD PASS WITHOUT COMPLICATION AND IT COULD BE EXPANDED. FILTER WAS NOT COMPLETELY EXPANDED AS RESULTS OF THE PRODUCT CONDITIONS. FOR THE NOTED KINK AND NEAR SEPARATION DAMAGES ON THE CSI AND TIP DAMAGE OF THE VESSEL DILATOR THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. A 100% VISUAL INSPECTION ARE IN PLACE TO INSPECT IF THERE IS AN ISSUE FOR DAMAGES IN THE CSI SHEATH AND VESSEL DILATOR BEFORE THE PRODUCT LEAVES THE FACILITY. 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 REPORTED FILTER IMPEDED WAS CONFIRMED. THE EXACT CAUSE OF THE FILTER STUCK IN THE SHEATH WAS CAUSED DUE TO ONE BARD HAD PENETRATED THE SHEATH; HOWEVER THIS CONDITION OF THE BARB IN THE SHEATH COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. CONTROLS ARE IN PLACE TO INSPECT THE FILTER LOADING AND CSI BEFORE IT LEAVES THE FACILITY. IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS AND/OR VESSEL CHARACTERISTICS.

    Description of Event or Problem · 1

    WHEN THE (CSI) CATHETER SHEATH INTRODUCER WAS POSITIONED TO LESION, THE PHYSICIAN DELIVERED THE FILTER, BUT FOUND IT WAS NOT SMOOTH TO PASS THE THROUGH THE CSI. AFTER WITHDRAWAL THE FILTER AND CATHETER, THE CSI WAS BROKEN BY THE FILTER. THE PHYSICIAN CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. A BARB FROM THE FILTER WAS NOT PROTRUDING THROUGH THE SHEATH. DURING INSERTION OF THE FILTER, CONSTANT FLUOROSCOPY WAS PERFORMED. THE SHEATH WAS NOT KINK OR BEND. THE OBTURATOR DID NOT REMAIN FIXED WHILE THE DEPLOYMENT SHEATH WAS PULLED BACK OVER THE OBTURATOR. THROMBUS WAS PRESENT AT DELIVERY SITE. THE PATIENT RECEIVED ANTICOAGULATION, BUT THE MEDICATION IS UNKNOWN. THE PATIENT DID NOT HAVE RECURRENT PE IN SPITE OF ANTICOAGULATION. PRE/POST IMAGING WAS COMPLETED. PROCEDURAL FILMS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA R1108014

    Patients

    Seq Age Sex Outcome Treatment
    1 CSI