BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 5694300 · Received June 2, 2016

    Report

    Report Number
    1820334-2016-00480
    Event Type
    Injury
    Date Received
    June 2, 2016
    Report Date
    September 21, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION- THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION WAS PROVIDED REGARDING THE EVENT. 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. NO NOTES OF RELEVANCE FOUND IN THE DEVICE WORK ORDER, NOR ON THE FILTER LOT NUMBER. DEVICE MANUFACTURED/INSPECTED ACCORDING TO SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST A DEVICE FAILURE. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE REOPENED FOR FURTHER INVESTIGATION

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM, SERIOUS INJURY TO MALFUNCTION. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    CORRECTION: ADVERSE EVENT; SERIOUS INJURY. 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 (BACK AND KNEE PAIN; NUMBNESS ON RIGHT SIDE OF BODY; NEEDS ASSISTANCE TO WALK). IT IS UNKNOWN IF THE REPORTED (BACK AND KNEE PAIN; NUMBNESS ON RIGHT SIDE OF BODY; NEEDS ASSISTANCE TO WALK) IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT PATIENT RECEIVED A COOK GUNTHER TULIP 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 NOT BEEN PROVIDED. PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT, "PATIENT RECEIVED A COOK GUNTHER TULIP 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 NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 06/20/21016 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED A FILTER IMPLANT ON (B)(6) 2006 AS PE PROPHYLAXIS PRIOR TO GASTRIC BYPASS SURGERY. THE PLAINTIFF ALLEGES BACK PAIN, KNEE PAIN, NUMBNESS ON RIGHT SIDE OF BODY, AND NEEDING ASSISTANCE TO WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349727 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other