BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6092159 · Received November 10, 2016

    Report

    Report Number
    1820334-2016-01190
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    August 11, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION- THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT WAS PROVIDED. NO NOTES OF RELEVANCE FOUND IN THE DEVICE WORK ORDER, NOR ON THE FILTER LOT NUMBER. NO OTHER COMPLAINTS HAVE BEEN RECEIVED RELEVANT TO THIS LOT. IMPOSSIBLE TO COMMENT ON THE ALLEGED INJURIES. 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

    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 ¿PAIN, SWELLING, ULCERS". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. IT IS UNKNOWN IF THE REPORTED PAIN, SWELLING, OR ULCERS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    WILLIAM COOK (B)(4) INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2016-00002. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. AN UPDATED EMDR REPORT WAS SUBMITTED UNDER COOK INC. MFR REPORT # 1820334-2016-01190, FOLLOW UP #1 THIS WAS IN REFERENCE TO WILLIAM COOK (B)(4) MFR REPORT # 3002808486-2016-00002. COOK IS NOW SUBMITTING AN INITIAL REPORT TO CORRECT THIS ISSUE. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. (B)(4). EVALUATION- THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT WAS PROVIDED. NO NOTES OF RELEVANCE FOUND IN THE DEVICE WORK ORDER, NOR ON THE FILTER LOT NUMBER. NO OTHER COMPLAINTS HAVE BEEN RECEIVED RELEVANT TO THIS LOT. IMPOSSIBLE TO COMMENT ON THE ALLEGED INJURIES. 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.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2010 AT (B)(6) MEDICAL CENTER IN (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 06/16/2016 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DVT AND GI BLEED. PLAINTIFF IS ALLEGING PAIN, SWELLING, ULCERS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2010 AT (B)(6) MEDICAL CENTER IN (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746049 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 Other