BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 5900833 · Received August 24, 2016

    Report

    Report Number
    1820334-2016-00868
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Report Date
    July 26, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM) CHANGED TO: IT IS ALLEGED THAT "THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2006 AT (B)(6)." IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS ALSO SEEKING PUNITIVE DAMAGES. MEDICAL RECORDS HAVE BEEN REQUESTED, BUT HAVE YET TO BE PROVIDED. (B)(4). EVALUATION- NO INFORMATION REGARDING THE EVENT WAS PROVIDED. THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. UNABLE TO COMMENT ON THE ALLEGED INJURY. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K) IS K043509. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING: "PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED. HOWEVER, IT WAS REPORTED THAT THERE WERE NO ATTEMPTED RETRIEVALS". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED (E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA). FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2006 AT (B)(6) HOSPITAL CENTER IN (B)(6). DR. (B)(6) ALLEGEDLY PLACED THE FILTER. IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS ALSO SEEKING PUNITIVE DAMAGES. MEDICAL RECORDS HAVE BEEN REQUESTED, BUT HAVE YET TO BE PROVIDED.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT "THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2006 AT (B)(6)." IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS ALSO SEEKING PUNITIVE DAMAGES. MEDICAL RECORDS HAVE BEEN REQUESTED, BUT HAVE YET TO BE PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 02/07/2017 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2006 VIA THE RIGHT FEMORAL VEIN APPROACH DUE TO DVT WITH PE. PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED. HOWEVER, IT WAS REPORTED THAT THERE WERE NO ATTEMPTED RETRIEVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553601 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other