BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH

    MDR report key: 6299607 · Received February 3, 2017

    Report

    Report Number
    3002808486-2017-00150
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). CATALOG#: IGTCFS-65-JP-JUG-TULIP. (B)(6). SIMILAR TO DEVICE UNDER 510(K) K090140 (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: SINCE NO IMAGES IT IS DIFFICULT TO COMMENT ON THE SUSPECTED HOOK AND FILTER LEG PERFORATION AND BASED ON LIMITED INFORMATION PROVIDED AN EXACT REASON CANNOT BE DETERMINED. ALSO, DIFFICULT TO COMMENT ON RETRIEVAL DIFFICULTIES SINCE REPORTED "LAPAROTOMY WAS PERFORMED TO ATTEMPT TO RETRIEVE THE FILTER NON INVASIVELY." NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IN (B)(6) 2012 THE FILTER WAS PLACED BY A PHYSICIAN IN THE CARDIOVASCULAR INTERNAL MEDICINE DEPARTMENT. FOLLOW-UP HISTORY AFTER THE PROCEDURE IS UNKNOWN. IVC PERFORATION BY THE FILTER HOOK AND LEG WAS SUSPECTED WITH DIAGNOSTIC IMAGING, THEN A REQUEST OF THE FILTER RETRIEVAL BY OPENING THE ABDOMEN WAS MADE TO THE CARDIOVASCULAR SURGERY DEPARTMENT. ON (B)(6) 2013, THOUGH VENOGRAPHY AND IVUS WERE PERFORMED IN THE CARDIOVASCULAR SURGERY DEPARTMENT, THESE COULD NOT MAKE A DEFINITIVE DIAGNOSIS. THE PHYSICIAN WILL MAKE A FINAL DECISION AFTER EXPLANATION TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 09JUL203: LAPAROTOMY IS SCHEDULED ON THE (B)(6) 2013 TO RETRIEVE THE FILTER. ADDITIONAL INFORMATION RECEIVED 08AUG2013: ON (B)(6) 2013, LAPAROTOMY WAS PERFORMED TO ATTEMPT TO RETRIEVE THE FILTER NON INVASIVELY. HOWEVER BECAUSE ADHESION WAS SEVERE, THE FILTER WAS RETRIEVED EVENTUALLY BY A CUTDOWN OF THE IVC. PATIENT OUTCOME: THERE HAS BEEN NO PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83748 GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 Required Intervention