BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 24698896 · Received March 26, 2026

    Report

    Report Number
    3002808486-2026-00057
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 26, 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

    MANUFACTURER REF # (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K): K233680. AFTER INVESTIGATION THE EVENT IS CONSIDERED REPORTABLE 16MAR2026. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS NOT POSSIBLE TO ADVANCE THE FEMORAL INTRODUCER WITH THE SELECT-PT FILTER THROUGH THE SHEATH. AFTER WITHDRAWAL FROM THE PATIENT THE FILTER LEGS OPENED OUTWARD. ¿THE COAXIAL SHEATH WAS WITHDRAWN¿, BUT REPORTEDLY, THE INTRODUCER SHEATH HAD BEEN ADVANCED WITHOUT THE INTRODUCER DILATOR INSIDE. 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 ENTIRE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE EVALUATION DETERMINED THE FOLLOWING: THE PRE-DILATOR, THE INTRODUCER DILATOR, JUGULAR INTRODUCER, THE INTRODUCER SHEATH, AND THE FEMORAL INTRODUCER WITH LOADED CELECT-PT FILTER WERE RETURNED. THE SECONDARY FILTER LEGS WERE OUT OF SHAPE, BUT STILL IT WAS POSSIBLE TO COLLAPSE THE FILTER AND ADVANCE IT THROUGH THE SHEATH. 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. COOK CONDUCTED A REVIEW OF THE PACKAGING LABEL (WHOLE DEVICE), WHICH REVEALED NO DISCREPANCIES. THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSES MAY INCLUDE ADVANCEMENT OF THE SHEATH WITHOUT THE DILATOR INSIDE. THE IFU STATES TO ADVANCE THE COAXIAL INTRODUCER SYSTEM OVER THE WIRE GUIDE UNTIL THE TIP OF THE INTRODUCER SHEATH LIES APPROX. 1CM CAUDAL TO THE LOWEST RENAL VEIN AND TO PERFORM DIAGNOSTIC IMAGING TO VERIFY THE SHEATH POSITION BEFORE REMOVING THE INTRODUCER DILATOR. 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: INFERIOR VENA CAVA FILTER IMPLANTATION PROCEDURE, WITH NORMAL PUNCTURE AND COAXIAL SHEATH IMPLANTATION. HOWEVER, WHEN PREPARING TO ADVANCE THE FILTER DELIVERY SYSTEM, IT WAS UNABLE TO ADVANCE NORMALLY AND WAS OBSTRUCTED. SUBSEQUENTLY, THE FILTER WAS WITHDRAWN, AND AFTER BEING RELEASED OUTSIDE THE BODY, IT WAS FOUND THAT THE MAIN FILTER WIRE OF THE FILTER OPENED OUTWARD. SUBSEQUENTLY, THE COAXIAL SHEATH WAS WITHDRAWN AND A NEW SET OF COOK FILTERS WAS PLACED. 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
    759822 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4754255 00827002355811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female