BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 22382950 · Received July 2, 2025

    Report

    Report Number
    3002808486-2025-00142
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 27, 2025
    Report Date
    October 3, 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). 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# CN-(B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT-PT FILTER ADVANCED FROM FEMORAL APPROACH DID NOT ¿DEPLOY LIKE IT SHOULD HAVE¿. ANOTHER FILTER WAS PLACED. NO REPORTED HARM TO THE PATIENT. ONLY THE CELECT-PT FILTER WAS RETURNED. TWO SECONDARY FILTER LEGS WERE SEVERELY DEFORMED AND ANOTHER TWO WERE SLIGHTLY OUT OF SHAPE. THE DAMAGE SUGGESTS THE FILTER AND THE FEMORAL INTRODUCER HAD BEEN ROTATED INSIDE THE SHEATH OR WITHDRAWN THROUGH THE SHEATH HUB AND AS THE FILTER REPORTEDLY WAS REMOVED AND REPLACED WITHOUT ANY HARM TO THE PATIENT, IT IS ASSUMED THAT THE REPORTED DEPLOYMENT ISSUE COVERED DIFFICULTIES IN ADVANCING THE FILTER THROUGH THE SHEATH. DURING MANUFACTURING THE FEMORAL INTRODUCER MUST BE ADVANCED THROUGH THE SHEATH TO VERIFY SMOOTH ADVANCEMENT AND THE INSTRUCTIONS FOR USE WARN NOT TO ROTATE THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM AND NOT TO EXERT EXCESSIVE FORCE TO ADVANCE THE FILTER THOUGH THE INTRODUCER SYSTEM. HOWEVER, AS THE SHEATH WAS NOT RETURNED FOR ANALYSIS, BASED ON THE LIMITED INFORMATION PROVIDED THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED CANNOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, 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: G34505 BATCH NUMBER E4671763 HAD AN ISSUE IN A PROCEDURE. IT DIDN¿T DEPLOY LIKE IT SHOULD HAVE.

    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
    19036 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34505 E4671763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown