BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 23591377 · Received November 19, 2025

    Report

    Report Number
    3002808486-2025-00243
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 31, 2025
    Report Date
    February 25, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002529168
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K233680. E1) PHONE NUMBER (B)(6). INVESTIGATION IS STILL IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE TULIP FILTER DID NOT EXPAND CORRECTLY DURING PLACEMENT FROM JUGULAR APPROACH. DURING RETRACTION ATTEMPT THE FILTER CAME OFF THE HOOK AND WAS PLACED AT AN ANGLE. THE FILTER WAS REMOVED BY RETRIEVAL DEVICE AND ANOTHER FILTER WAS SUCCESSFULLY PLACED. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE HAS NOT PREVIOUSLY OCCURRED FOR THIS MANUFACTURING LOT. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION DUE TO LIMITED INFORMATION TO DETERMINE, SINCE NO IMAGING WAS PROVIDED AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. 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: THE USER RELEASED THE FILTER OF AN IGTCFS-65-1-JUG-TULIP FROM THE SHEATH AND ATTEMPTED TO DEPLOY, HOWEVER, THE FILTER DID NOT EXPAND CORRECTLY. THOUGH THE USER ATTEMPTED TO RETRACT THE FILTER INTO THE SHEATH, THE FILTER CAME OFF THE HOOK AND WAS PLACED AT AN ANGLE. THE USER RETRIEVED THE FILTER AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218524 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E4651564 00827002529168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown