BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER

    MDR report key: 1811105 · Received August 23, 2010

    Report

    Report Number
    9610978-2010-00161
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A VENA CAVA FILTER IMPLANTATION, RESISTANCE/FRICTION WAS ENCOUNTERED WHILE ATTEMPTING TO INSERT THE SHEATH INTO THE VESSEL. THE DEVICE WAS REMOVED AND THE DISTAL END OF THE SHEATH WAS FOUND TO BE FRAYED. ANOTHER TRAPEASE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THE DEVICE WAS PREPARED AND HANDLED ACCORDING TO THE IFU. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. REVIEW OF LOT 15111522 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. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR FILTER IMPLANTATION FOR A DVT PATIENT, INSERTION DIFFICULTY WAS EXPERIENCED WITH THE BRITE TIP SHEATH. THE PUNCTURE WAS MADE FROM THE RIGHT JUGULAR VEIN. THE GUIDEWIRE WAS LEFT INSERTED IN THE PATIENT, AND THE DEVICE WAS REMOVED. THE DISTAL END OF THE SHEATH WAS FOUND TO BE FRAYED, AND THE DILATOR WAS NOT SNAPPED INTO THE END OF THE BRITE TIP SHEATH. ANOTHER TRAPEASE FROM A DIFFERENT LOT WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THE DEVICE WAS PREPARED AND HANDLED ACCORDING TO THE IFU. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THERE WILL BE NO PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS EUROPA, N.V. NA 15111522

    Patients

    Seq Age Sex Outcome Treatment
    1 RADIFOCUS 0.035" GUIDEWIRE