BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 25146515 · Received May 12, 2026

    Report

    Report Number
    3002808486-2026-00083
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 11, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002355811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE PROCEDURE, THE SHEATH WAS ADVANCED OVER THE WIRE GUIDE TO A POSITION ABOVE THE RENAL VEINS IN PREPARATION FOR FILTER DEPLOYMENT. WHEN INSERTING THE FILTER INTO THE SHEATH, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED GENTLE FORCE TO ADVANCE THE FILTER INTO THE SHEATH, BUT THE FILTER THEN BECAME STUCK AND COULD NOT BE PUSHED FORWARD. AN ATTEMPT WAS THEN MADE TO RETRACT AND REMOVE THE FILTER FROM THE SHEATH, WHICH RESULTED IN DEFORMATION OF THE FILTER. THE PHYSICIAN SUSPECTED AN OBSTRUCTION WITHIN THE LUMEN OF THE SHEATH. ANOTHER NEW FILTER WAS SUBSEQUENTLY USED TO CONTINUE THE PROCEDURE, AND NO SUCH ISSUES OCCURRED WITH THE SECOND FILTER. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441304 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4781634 00827002355811

    Patients

    Seq Age Sex Outcome Treatment
    1