BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER

    MDR report key: 2241008 · Received January 18, 2011

    Report

    Report Number
    3002808486-2011-00002
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    August 25, 2010
    Report Date
    December 16, 2010
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DATE SENT IS UNK AS NOT PROVIDED BY RPTR. CORRECTED DATA FROM THE USER FACILITY REPORT. COAXIAL INTRODUCER SHEATH AND FILTER ARE RETURNED TO ASSIST THE INVESTIGATION. INVESTIGATION CONFIRMS THAT FILTER LEGS HAVE PERFORATED THE SHEATH APPROX 35 CM FROM THE PROXIMAL END. ALSO, A SCRATCH IS NOTICED ON THE OUTSIDE OF THE SHEATH IN THE SAME AREA AS ONE OF THE PERFORATIONS. THIS SCRATCH IS MOST LIKELY CAUSED BY THE BARB ON THE PERFORATED PRIMARY FILTER LEG. THE FILTER IS STRONGLY DEFORMED, SUGGESTING THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DURING THE DEPLOYMENT PROCEDURE. HOWEVER, NOTHING INDICATED THAT THIS DEVICE WAS NOT MANUFACTURED WITHIN SPECIFICATIONS. APPROPRIATE INTERNAL PERSONNEL ARE INFORMED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. NO FURTHER ACTION IS INITIATED AT THIS TIME. ADD'L INFO FROM THE USER FACILITY REPORT: (B)(4), COOK CELECT FILTER SET FEMORAL AND JUGULAR APPR, IVC FILTER, COOK MEDICAL INC., (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING AN IVC FILTER PLACEMENT. WHILE INSERTING THE IVC FILTER THROUGH THE DELIVERY SHEATH, A LEG OF THE FILTER POKED THROUGH THE SHEATH. THE PHYSICIAN TRIED ADVANCING THE FILTER BUT DUE TO THE PT'S ANATOMY, THE SHEATH BECAME DAMAGED AND WAS UNABLE TO ADVANCE OR REMOVE THE FILTER. ANOTHER PHYSICIAN WAS CALLED TO THE ROOM AND A CUT DOWN AND VEINOTOMY WAS PERFORMED TO RETRIEVE THE IVC FILTER FROM THE PTS FEMORAL VEIN. THE PT IS DOING FINE BUT DID END UP WITH A 4 INCH INCISION INSTEAD OF A 1/4 INCH INCISION. THE STAFF DID NOT KNOW WHICH OF THE 2 PRODUCT PACKAGING INFO WAS FOR THE MALFUNCTIONED DEVICE OR FOR THE IMPLANTED DEVICE SO BOTH WERE PROVIDED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION. DR (B)(6) WAS PERFORMING AND IVC FILTER PLACEMENT. WHILE INSERTING IVC FILTER THROUGH DELIVERY SHEATH, A LEG OF THE FILTER POKED THROUGH THE SHEATH. TRIED ADVANCING THE FILTER BUT DUE TO PT'S ANATOMY, THE SHEATH BECAME DAMAGED AND WAS UNABLE TO ADVANCE OR REMOVE FILTER. DR (B)(6) WAS CALLED TO ROOM. CUT DOWN AND VEINOTOMY WAS PERFORMED TO RETRIEVE IVC FILTER FROM PTS FEMORAL VEIN. THE PT IS DOING FINE BUT DID END UP WITH A 4 INCH INCISION INSTEAD OF 1/4 INCH. THE STAFF DID NOT KNOW WHICH OF THE 2 PRODUCT PACKAGING INFO WAS FOR THE MALFUNCTIONED DEVICE OR FOR THE IMPLANTED DEVICE SO BOTH WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE NA E2561316/E2542637

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention