BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 5826643 · Received July 27, 2016

    Report

    Report Number
    1820334-2016-00695
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Report Date
    July 25, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. (B)(4). EVALUATION- THE DEVICE WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. IMPOSSIBLE TO COMMENT ON ALLEGED INJURIES. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE REOPENED FOR FURTHER INVESTIGATION. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    CORRECTED FROM BLANK TO PRODUCT PROBLEM TO MATCH PARENT. (B)(4)). 510(K) K032426 CORRECTED AE DECISION FROM SERIOUS INJURY TO MALFUNCTION THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    ACCORDING TO DEVICE HISTORY RECORDS, BASED ON THE LOT NUMBER PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G., THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. IT HAS NOT BEEN POSSIBLE TO FULLY INVESTIGATE OR EVALUATE THIS EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    EVALUATION: ACCORDING TO DEVICE HISTORY RECORDS, BASED ON THE LOT NUMBER PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G., THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA IN THE SITUATIONS DESCRIBED IN THE IFU. IT HAS NOT BEEN POSSIBLE TO FULLY INVESTIGATE OR EVALUATE THIS EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON OR ABOUT (B)(6) 2005 AT (B)(6) MEDICAL CENTER IN (B)(6). DR. (B)(6) ALLEGEDLY PLACED THE FILTER. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 08/12/2016 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2005 VIA THE RIGHT JUGULAR VEIN DUE TO DVT. PLAINTIFF IS NOT ALLEGING ANY OUTCOMES OR COMPLAINTS ATTRIBUTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478574 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other