BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6021266 · Received October 12, 2016

    Report

    Report Number
    1820334-2016-01103
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Report Date
    May 26, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). EVALUATION- NO INFORMATION REGARDING THE EVENT. 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 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) K032426. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

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

    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 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 COOK GUNTHER TULIP ON (B)(6) 2005 AT (B)(6) HOSPITAL IN (B)(6). IT IS ALLEGED THAT 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

    ADDITIONAL INFORMATION RECEIVED 2/28/17: THE PATIENT ALLEGEDLY RECEIVED DEVICE IMPLANT VIA RIGHT FEMORAL VEIN ON (B)(6) 2005. PATIENT ALLEGES THERE WAS AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DEVICE ON (B)(6) 2005 AND IS ALLEGING THE DEVICE IS EMBEDDED. PATIENT ALLEGES ANXIETY, ABDOMINAL PAIN AND CHEST PAIN.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE "PATIENT RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2005 AT (B)(6)." IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674522 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other