BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 23974233 · Received January 6, 2026

    Report

    Report Number
    3002808486-2026-00005
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 28, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002355811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INFERIOR VENA CAVA FILTER IMPLANTATION PROCEDURE FROM FEMORAL APPROACH WAS NORMAL, COAXIAL SHEATH IMPLANTATION WAS NORMAL, BUT WHEN PREPARING TO ADVANCE THE FILTER DELIVERY SYSTEM, IT COULD NOT BE ADVANCED NORMALLY AND WAS SIGNIFICANTLY OBSTRUCTED. WHEN ADVANCING THE FILTER DELIVERY SYSTEM AT THE HEAD END OF THE COAXIAL SHEATH, IT WAS OBSTRUCTED BY ABOUT 2CM, AND THEN THE FILTER DELIVERY SYSTEM WAS WITHDRAWN. THE FILTER GOT STUCK IN THE FRONT SECTION OF THE COAXIAL SHEATH, AND THEN THE COAXIAL SHEATH WAS WITHDRAWN, AND THE KESSEL FILTER WAS USED TO COMPLETED THE PROCEDURE. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSE IS IF ANY ANATOMICAL CONDITIONS COULD HAVE CAUSED ADVANCEMENT DIFFICULTIES THROUGH THE SHEATH WHEN TRYING TO ADVANCE INSIDE THE PATIENT. THE DOCUMENT REVIEW FOUND DOCUMENTATION ENSURING THE FEMORAL INTRODUCER CAN PASS THROUGH THE INTRODUCER SHEATH BEFORE FINAL RELEASE. 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.

    Additional Manufacturer Narrative · 0

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

    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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFERIOR VENA CAVA FILTER IMPLANTATION PROCEDURE (FEMORAL APPROACH), INTRAOPERATIVE PUNCTURE WAS NORMAL, COAXIAL SHEATH IMPLANTATION WAS NORMAL, BUT WHEN PREPARING TO ADVANCE THE FILTER DELIVERY SYSTEM, IT COULD NOT BE ADVANCED NORMALLY AND WAS SIGNIFICANTLY OBSTRUCTED. WHEN ADVANCING THE FILTER DELIVERY SYSTEM AT THE HEAD END OF THE COAXIAL SHEATH, IT WAS OBSTRUCTED BY ABOUT 2CM, AND THEN THE FILTER DELIVERY SYSTEM WAS WITHDRAWN. THE FILTER GOT STUCK IN THE FRONT SECTION OF THE COAXIAL SHEATH, AND THEN THE COAXIAL SHEATH WAS WITHDRAWN, AND THE KESSEL FILTER WAS USED TO COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38828 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4673157 00827002355811

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male