BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER 90CM

    MDR report key: 1820550 · Received August 31, 2010

    Report

    Report Number
    9610978-2010-00169
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 4, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 6F BRITE TIP DELIVERY SHEATH. WHILE ADVANCING THE FILTER THROUGH THE DELIVERY SHEATH IT BECAME STUCK JUST PAST THE BEND IN THE ILIAC. THE PHYSICIAN PUSHED THE DEVICE WITH SOME FORCE TO MOVE IT BUT THE BARBS BECAME STUCK IN THE SHEATH AND WERE NOTED TO BE PROTRUDING THROUGH IT. THE PATIENT HAD A VERY TORTUOUS VENOUS ANATOMY AND IT WAS EXTREMELY DIFFICULT JUST TO GET THE SHEATH IN PLACE. THE PRODUCT WAS PRODUCT STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE AND IT WAS EASILY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY. A NON STERILE TRAPEASE 90CM CSI WAS RECEIVED COILED AND INSIDE A BAG. THE RETURNED DEVICE INCLUDES THE OBTURATOR, CSI (SHEATH), FILTER AND FILTER CARTRIDGE. IT WAS NOTED THAT THE FILTER WAS STUCK WITHIN THE SHEATH, AND IT PRESENTS RESIDUES OF BLOOD. ONE BARB WAS PROTRUDING THE SHEATH. NO KINKS OR OTHER ANOMALY WERE OBSERVED IN THE CSI. THE FILTER BARBS WERE REVIEWED UNDER MICROSCOPE AT 25X OF MAGNIFICATION AND NO ANOMALIES WERE NOTED IN THE BARBS. AN ATTEMPT TO ADVANCE THE FILTER THROUGH THE CSI WAS DONE PER DP 12169747 REV 1 AND THE FILTER PASSED WITHOUT RESISTANCE AND NO FRICTION WAS FELT. THE FILTER WAS NOT EXPANDED COMPLETELY DUE TO CONDITION OF THE PRODUCT AS RECEIVED. 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-PERFORATION SHEATH WAS CONFIRMED AND THE CSI INSERTION DIFFICULTY REPORTED ALSO WAS NOT CONFIRMED. HOWEVER IT COULD NOT BE CONCLUSIVELY DETERMINED THE CAUSE OF THE FILTER STUCK ON THE CSI SHEATH. 100% VISUAL INSPECTION IS IN PLACE TO INSPECT IF THERE IS AN ISSUE FOR DAMAGES IN THE CSI SHEATH BEFORE THE PRODUCT LEAVES THE FACILITY. 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. THE PATIENT'S DIFFICULT ANATOMY AND PROCEDURAL MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PREVIOUS REPORT INDICATED THAT THE "THE BARKS BECAME STUCK IN THE SHEATH AND WERE PROTRUDING" BUT SHOULD HAVE SAID THE BARBS WERE STUCK INSTEAD. NO OTHER CORRECTIONS ARE REQUIRED. NO OTHER INFORMATION IS AVAILABLE AND NO ADDITIONAL REPORTS WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    A TRAPEASE IVC FILTER GOT STUCK INSIDE THE 6F BRITETIP DELIVERY SHEATH. THE PATIENT HAD A VERY TORTUOUS VENOUS ANATOMY AND IT WAS EXTREMELY DIFFICULT TO JUST GET THE SHEATH IN PLACE. ONCE THE FILTER WOULD NOT PASS THROUGH THE SHEATH, AND IT WAS STUCK JUST PAST THE BEND IN THE ILIAC. THE PHYSICIAN PUSHED THE DEVICE WITH SOME FORCE TO MOVE IT BUT THE BARKS BECAME STUCK IN THE SHEATH AND WERE PROTRUDING. THE TECH PREPPED THE OTHER LEG AND PROCEEDED WITH THE PROCEDURE PLACING AN ADDITIONAL FILTER WITH EASE THROUGH THE SHEATH AND ULTIMATELY IN THE IVC OF THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE AS THE RESULT OF THE FILTER STUCK INSIDE THE SHEATH OR BY AN ADDITIONAL FILTER BEING OPENED. THE PRODUCT WILL BE RETURNED WITH THE FILTER STUCK INSIDE OF THE BRITE TIP SHEATH. THE PRODUCT WAS PRODUCT STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE AND IT WAS EASILY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER 90CM THROMBECTOMY SYSTEMS (DQO) DTK CORDIS EUROPA, N.V. NA 15153992

    Patients

    Seq Age Sex Outcome Treatment
    1