BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 18259239 · Received December 4, 2023

    Report

    Report Number
    3002808486-2023-00280
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    September 25, 2023
    Report Date
    November 28, 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. DATE AWARE FOR THIS EVENT WAS 26SEP2023 AT THE TIME IS WAS DEEMED NOT REPORTABLE HOWEVER INVESTIGATION DETERMINED 24NOV2023 THAT THERE WAS RISK FOR PATIENT HARM IF IT WERE TO RECUR, AND THEREBY THIS EVENT BECAME REPORTABLE AS A MALFUNCTION. G4) SIMILAR TO DEVICE UNDER PMA/510(K) K211874. SUMMARY OF INVESTIGATIONAL FINDINGS: THE TULIP FILTER RELEASED INSIDE THE SHEATH DURING ATTEMPT TO RE-SHEATH IT. ANOTHER FILTER WAS SUCCESSFULLY PLACED. THE BLUE INTRODUCER SHEATH WAS RETURNED WITH THE JUGULAR INTRODUCER AND THE RELEASED FILTER INSIDE PROTECTION SHEATH. THE INTRODUCER HAD KINKED 50MM FROM THE HANDLE AND INTRODUCER/PROTECTION SHEATH HAD KINKED 54MM FROM THE DISTAL TIP. DENTS WERE NOTED IN THE DISTAL TIP OF THE PROTECTION SHEATH AND THE GRASPING HOOK HAD SLIGHTLY STRAIGHTENED. BASED ON THESE INVESTIGATION FINDINGS THE EXACT REASON FOR THE FILTER TO RELEASE INSIDE THE PROTECTION SHEATH CANNOT BE DETERMINED, BUT THE SLIGHTLY STRAIGHTENED GRASPING HOOK INDICATES THE DEVICES WERE EXPOSED TO MANIPULATION BEYOND THEIR DESIGN DURING ATTEMPTS TO RE-SHEATH THE FILTER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL RELEASE, THERE IS EVIDENCE THAT THE DEVICE HISTORY RECORD 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: (B)(6) 2023: AFTER THE USER DEPLOYED THE FILTER, HE WAS ATTEMPTING TO RE-SHEATH THE FILTER, AND THE FILTER HOOK WAS RELEASED FROM THE FILTER CATHETER WITHOUT INTENTION. THE FILTER WAS INSIDE THE CATHETER SHEATH AT THE UNINTENDED RELEASE, SO HE REMOVED THE WHOLE SYSTEM WITH THE FILTER INSIDE FROM THE PATIENT BODY AND ENDED THE PROCEDURE. (B)(6) 2023: HE CONDUCTED ANOTHER FILTER PLACEMENT USING ANOTHER IGTCFS-65-1-JUG-TULIP AND PLACED A FILTER SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT HAD TO BE UNDER SECOND FILTER PLACEMENT NEXT DAY. ALTHOUGH THE PATIENT IS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158823 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4409930 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown