BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER

    MDR report key: 1770206 · Received July 21, 2010

    Report

    Report Number
    1820334-2010-00328
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 21, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT - UNK AS NOT PROVIDED BY REPORTER. EXPIRATION - UNK AS LOT IS UNK. (B)(4): BACK PAIN. THE CUSTOMER RETURNED ONE FILTER IN AN USED CONDITION. APPROX 1.5 CM OF ONE OF THE PRIMARY LEGS AND A PORTION OF THE SAME CORRESPONDING SECONDARY LEG WAS MISSING. ADDITIONALLY, THE HOOK OF THE FILTER APPEARED TO HAVE BEEN STRAIGHTENED. BIOMATTER IS COVERING THE ENDS OF THE THREE REMAINING PRIMARY LEGS. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU STATES THAT, "MANIPULATION OF PRODUCTS REQUIRES FLUOROSCOPIC CONTROL." THE RISK WAS ASSESSED AND NO ACTION IS NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE COMPANY PERSONNEL.

    Description of Event or Problem · 1

    THE PT HAD BEEN COMPLAINING OF BACK PAIN. THE PHYSICIAN DID NOT KNOW IF THIS WAS DUE TO THE FILTER. PT SCHEDULED FOR IVC FILTER REMOVAL. UPON RETRIEVAL OF FILTER INTERVENTIONAL RADIOLOGIST REQUESTED THAT THE FILTER BE SENT BACK TO MFR FOR ANALYSIS DUE TO CROSSED LEGS AND FRACTURE OF 1 LEG. ADD'L INFO RECEIVED 07/01/2010: ALTHOUGH THE CALL FROM SUPPLY CHAIN AND MATERIALS MANAGEMENT AT THE FACILITY REPORTED THAT THE STRUTS OF THE FILTER WERE CROSSED, BOTH THE PHYSICIAN AND IMAGES OF PRE-RETRIEVAL WILL SHOW THAT THIS IS NOT THE CASE. THE PHYSICIAN HAS ASSURED THE REP THAT THE LEGS LIKELY CROSSED DURING THE SHEATHING PROCESS OF SUCCESSFULLY RETRIEVING THE FILTER. THE ONLY ISSUE AT THIS TIME IS THE FRACTURED STRUT. PT OUTCOME WAS NOT PROVIDED BY REPORTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention