BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 15368340 · Received September 7, 2022

    Report

    Report Number
    3002808486-2022-00939
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    June 8, 2022
    Report Date
    September 7, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER K211874. SUMMARY OF INVESTIGATIONAL FINDINGS: DURING ANGIOGRAPHY IT WAS DISCOVERED THAT THE SHEATH HAD KINKED APPROX. 15CM FROM THE HUB AND THAT BLOOD LEAKED FROM THE KINK. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. THE COAXIAL INTRODUCER SYSTEM WAS RETURNED AND AN INVESTIGATION OF THE SHEATH REVEALED A PENETRATION 513MM FROM THE DISTAL END AND A KINK AT THE BACK OF THE PENETRATION. THE PENETRATION SEEMED TO START FROM INSIDE AND WAS LIKELY CAUSED BY A FILTER LEG. BASED ON THESE FINDINGS AND THE INFORMATION PROVIDED THE EXACT REASON FOR THE PENETRATION CANNOT BE DETERMINED, BUT THE SHEATH MAY KINK IF ADVANCED THROUGH TORTUOUS ANATOMY AND THE FILTER MAY BE PRONE TO EXCEED THE SHEATH WALL, IF ADVANCED THROUGH A KINKED SHEATH. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE WARN THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO ADVANCE THE FILTER THROUGH THE DELIVERY SYSTEM AND SPECIFY IN DETAIL HOW TO ADVANCE THE FILTER WITH THE FILTER INTRODUCER INTO THE INTRODUCER SHEATH AND FOLLOWING HOW TO CONNECT THE COMPONENTS TO POSITION THE FILTER AT THE RADIOPAQUE BAND OF THE INTRODUCER SHEATH BEFORE THE SHEATH IS WITHDRAWN AND THE FILTER IS RELEASED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS DEVICE IS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FOR CLOTS PREVENTION PURPOSE PRIOR TO PLANNED SURGERY, IVC FILTER PLACEMENT PROCEDURE WAS PERFORMED. THE USER INSERTED THE INTRODUCER SHEATH FROM THE RIGHT JUGULAR VEIN. THEN HE PERFORMED ANGIOGRAPHY AND DURING ANGIOGRAPHY, HE FOUND A KINK IN THE SHEATH AND BLOOD LEAKAGE FROM THE KINKED SITE. IT WAS APPROX. 15CM FROM THE HUB. SO HE OPENED ANOTHER ONE TO REPLACE THE SHEATH TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399737 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E4191918 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown