BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 22782085 · Received August 12, 2025

    Report

    Report Number
    3002808486-2025-00183
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    April 23, 2025
    Report Date
    August 12, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002345041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. DATE OF AWARENESS 30APR2025. ACCORDING TO INVESTIGATION COMPLETED ON 31JUL2025 SIMILAR INCIDENTS HAS PREVIOUSLY BEEN REPORTED AND THEREFORE THE EVENT IS NOW REPORTABLE. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K233680. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER HAD EXTREME DIFFICULTY SLIDING THROUGH THE SHEATH WHEN EXPOSING IT, ENDING UP DAMAGING THE FIXING RODS. ASSUMINGLY ANOTHER FILTER WAS PLACED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS, BUT PHOTOS PROVIDED SHOWED INTACT DEVICE COMPONENTS. HOWEVER, THE CELECT-PT FILTER WAS STILL LOADED TO THE FEMORAL INTRODUCER BUT WAS SEVERELY DAMAGED WITH THE SECONDARY FILTER LEGS BENDING UPWARDS AGAINST THE FILTER HOOK. BASED ON THE PHOTOS AND THE INFORMATION PROVIDED THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED DURING ATTEMPT TO ADVANCE THE FILTER THROUGH THE SHEATH FROM FEMORAL APPROACH CANNOT BE DETERMINED. DURING MANUFACTURING THE FEMORAL INTRODUCER MUST BE ADVANCED THROUGH THE SHEATH TO VERIFY SMOOTH ADVANCEMENT, BUT THE SECONDARY FILTER LEGS WERE LIKELY DAMAGED, WHEN WITHDRAWING THE FILTER THROUGH THE SHEATH/VALVE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE IS 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 NON-CONFORMING 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: AS REPORTED ON THE CUSTOMER COMPLAINT FORM: THE FILTER HAD EXTREME DIFFICULTY SLIDING THROUGH THE SHEATH WHEN EXPOSING IT, ENDING UP DAMAGING THE FIXING RODS. PATIENT OUTCOME: NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419574 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34504 E4630661 00827002345041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown