BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 22369179 · Received July 1, 2025

    Report

    Report Number
    3002808486-2025-00141
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 16, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ROUTINE CELECT-PT FILTER INSERTION FROM FEMORAL APPROACH TO POINT OF ADVANCING FILTER INTO AND UP SHEATH. MOVED 20CM IN THEN COULD NOT ADVANCE. CAREFULLY REMOVED/CHECKED FILTER REATTEMPTED SAME DISTANCE OBSTRUCTION. THE INTRODUCER SHEATH, THE INTRODUCER DILATOR, AND THE FEMORAL INTRODUCER WITH LOADED CELECT-PT FILTER WERE RETURNED. ON THE INTRODUCER SHEATH A KINK WAS NOTED 13MM FROM THE HUB AND ON THE FILTER A SECONDARY FILTER LEG WAS SEVERELY DAMAGED AND PUSHED UPWARDS. THE EXACT REASON WHY THE FEMORAL INTRODUCER COULD NOT BE ADVANCED THROUGH THE SHEATH CANNOT BE DETERMINED. DURING MANUFACTURING THE FEMORAL INTRODUCER MUST BE ADVANCED THROUGH THE SHEATH TO VERIFY SMOOTH ADVANCEMENT BUT BASED ON THE INVESTIGATION FINDINGS IT IS SUGGESTED THAT THE INTRODUCER SHEATH SOMEHOW KINKED DURING ADVANCEMENT/POSITIONING AND THAT THE KINK PREVENTED ADVANCEMENT OF THE FILTER AND THE FEMORAL INTRODUCER INSIDE. FOLLOWING, THE SECONDARY FILTER LEG WAS LIKELY DAMAGED DURING WITHDRAWAL, IF NOT UNINTENDEDLY ROTATED DURING ADVANCEMENT. THE INSTRUCTIONS FOR USE WARN NOT TO ROTATE THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM. THE EXACT REASON WHY THE PROTECTION SHEATH HAD PASSED THE TACTILE BUMP CANNOT BE DETERMINED, BUT DAMAGE INSIDE THE HUB SUGGESTS SOME MANIPULATION WHEN COLLAPSING THE FILTER AND RELOADING IT FROM THE FEMORAL TO THE JUGULAR INTRODUCER. THE INSTRUCTIONS FOR USE SPECIFY HOW TO RELOAD THE FILTER AND TO ADVANCE THE PROTECTION SHEATH HUB ON THE JUGULAR FILTER INTRODUCER UNTIL A CONFIRMED STOP IS FELT, AS THIS WILL ENSURE THAT THE FILTER IS COMPLETELY INSIDE THE TIP OF THE CATHETER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH PROCEDURES AND ACCORDING TO SPECIFICATIONS. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCTS EXIST 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: ROUTINE FILTER INSERTION TO POINT OF ADVANCING FILTER INTO AND UP SHEATH. MOVED 20CM IN THEN COULD NOT ADVANCE. CAREFULLY REMOVED/CHECKED FILTER REATTEMPTED SAME DISTANCE OBSTRUCTION. REMOVED AND MANGLED FILTER DOING SO.

    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
    1313285 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34501 E4639121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown