BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER SET - JUGULAR APPROACH

    MDR report key: 1081808 · Received July 23, 2008

    Report

    Report Number
    1820334-2008-00392
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    COOK INC.
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. HOWEVER, WE COULD NOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THIS EVENT AT THIS TIME. THE DEVICE IS SHIPPED WITH AN "INSTRUCTIONS FOR USE" BOOKLET THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS MATTER AND WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS. AT THIS TIME, NO EVIDENCE EXISTS TO CONTRADICT THE SUBSTANCE OF THE COMPLAINT. AT THIS TIME, NO FURTHER RISK REDUCTION ACTIVITIES WILL BE INITIATED AND THE ASSOCIATED RISKS HAVE BEEN DEEMED ACCEPTABLE. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    PHYSICIAN WENT TO UNSHEATH FILTER (JUGULAR APPROACH), THE PRIMARY STRUT DID NOT EXPAND WITHIN IVC. PHYSICIAN RE-SHEATHED THE FILTER TO REMOVE FROM SHEATH, UPON REMOVING YELLOW CATHETER WITH ATTACHED FILTER, FILTER DEPLOYED WITHIN OUTER SHEATH. AT 8.5 FR SHEATH WAS THEN REMOVED WITH FILTER DEPLOYED INSIDE. FEET OF THE FILTER WERE REPORTED TO "CATCH" AT PUNCTURE SITE UPON REMOVAL. PHYSICIAN THEN HAD TO CLAMP AT PUNCTURE SITE AND PERFORM CUT DOWN TO REMOVE. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUNTHER TULIP VENA CAVA FILTER SET - JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC. NA 2062515

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention