BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 1951132 · Received January 6, 2011

    Report

    Report Number
    9610978-2011-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE FIELD INDICATED THAT WHILE THE PHYSICIAN WAS ADVANCING THE OPTEASE IVC RETRIEVAL FILTER THROUGH THE CATHETER SHEATH INTRODUCER, THE FILTER CUT THROUGH THE SHEATH. THE PHYSICIAN USED ANOTHER OPTEASE FILTER TO TREAT THE PATIENT AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED DIFFICULTY INSERTING THE CSI. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE AND NO PROBLEMS WERE NOTED. THERE WERE NO ACUTE BENDS AND NO PROBLEM ADVANCING THE GUIDEWIRE USED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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 15163184 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. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15163184. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT WHILE THE PHYSICIAN WAS ADVANCING THE OPTEASE IVC RETRIEVAL FILTER THROUGH THE CATHETER SHEATH INTRODUCER, THE FILTER CUT THROUGH THE SHEATH. THE PHYSICIAN USED ANOTHER OPTEASE FILTER TO TREAT THE PATIENT AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED DIFFICULTY INSERTING THE CSI. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND NO PROBLEMS WERE NOTED. THERE WERE NO ACUTE BENDS AND NO PROBLEM ADVANCING THE GUIDEWIRE USED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA 15163184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR