BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 18309509 · Received December 12, 2023

    Report

    Report Number
    3002808486-2023-00295
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    October 2, 2023
    Report Date
    December 12, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF( B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. RECEIVED BY MANUFACTURER 02OCT2023 AND ASSESSED NOT REPORTABLE HOWEVER INVESTIGATION FINDINGS CHANGE ASSESSMENT TO REPORTABLE 29NOV2023. G4) SIMILAR TO DEVICE UNDER PMA/510(K) K211874. SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER ADVANCEMENT FROM JUGULAR APPROACH THE TULIP FILTER RELEASED IN THE SHEATH DURING ATTEMPT TO REPOSITION. AFTER REMOVING THE JUGULAR INTRODUCER, THE FILTER WAS CAUGHT BY A LOOPED WIRE AND SHEATH AND FILTER WERE REMOVED. ANOTHER TULIP FILTER WAS SUCCESSFULLY PLACED WITH NO REPORTED HARM TO THE PATIENT. THE TULIP FILTER ATTACHED TO A NON-COOK RETRIEVAL LOOP INSIDE A NON-COOK CATHETER WERE RETURNED INSIDE THE BLUE INTRODUCER SHEATH. THE FILTER/LOOP/CATHETER STUCK IN HARDENED BLOOD INSIDE THE SHEATH AND COULD ONLY BE REMOVED BY CUTTING OPEN THE SHEATH. AFTER REMOVAL NO NON-CONFORMANCES WERE NOTED TO THE INTRODUCER SHEATH NOR THE TULIP FILTER/FILTER HOOK. BASED ON THESE INVESTIGATION FINDINGS AND SINCE THE JUGULAR INTRODUCER WAS NOT RETURNED THE EXACT REASON, WHY THE FILTER RELEASED IN THE SHEATH DURING RE-POSITIONING CANNOT BE DETERMINED. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. 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 21 CFR 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: APPROACHED FROM THE RIGHT JUGULAR VEIN TO THE INFERIOR VENA CAVA. THE DEVICE WAS ADVANCED TO THE IMPLANTATION POSITION AND THE FILTER WAS EXPANDED, BUT WHEN IT WAS RE-STOWED INTO THE DELIVERY SHEATH TO ADJUST THE IMPLANTATION POSITION, THE DELIVERY CATHETER (FILTER CATHETER) WAS FOUND TO BE DETACHED FROM THE FILTER. THEREFORE, THE DELIVERY CATHETER (FILTER CATHETER) WAS COMPLETELY REMOVED, A 0.014 WIRE GUIDE WAS LOOPED AND BROUGHT INTO THE SHEATH, HOOKED ONTO THE HOOK OF THE FILTER, AND THE DELIVERY SHEATH WAS REMOVED (BECAUSE IT COULD FALL OUT INTO THE BODY IF REMOVED AS IS). THE PROCEDURE WAS COMPLETED BY USING ANOTHER IGTCFS-65-1-JUG-TULIP WITH A DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579784 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4432139 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown