BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 19700147 · Received July 9, 2024

    Report

    Report Number
    3002808486-2024-00127
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 9, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BASED ON INVESTIGATIONAL FINDINGS THE EVENT IS NOW CONSIDERED REPORTABLE. G4) PMA/510(K): K211875. SUMMARY OF INVESTIGATIONAL FINDINGS: THE CELECT-PT FILTER DID NOT EXPAND, AS A COUPLE OF LEGS ¿STUCK TOGETHER¿. THE FILTER WAS REMOVED, ASSUMINGLY WITH THE JUGULAR INTRODUCER AND ASSUMINGLY NOT RELEASED FROM JUGULAR INTRODUCER, AS NO FURTHER INTERVENTIONS WERE REQUIRED. ANOTHER FILTER WAS SUCCESSFULLY PLACED. NO DEVICE WAS RETURNED. THEREFORE, BASED ON THE INFORMATION PROVIDED ONLY IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE PREVENTED THE FILTER LEGS FROM EXPANDING DURING DEPLOYMENT, BUT THE FILTER LEGS MAY BE SOMEHOW OBSTRUCTED FROM FULLY EXPANDING IF THE FILTER IS DEPLOYED IN A THROMBUS, OR IF THE FILTER LEGS ARE CAUGHT IN A CLOT. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE SPECIFY STEP-BY-STEP HOW TO PLACE THE SHEATH/JUGULAR INTRODUCER SYSTEM AND WITHDRAW THE INTRODUCER SHEATH AND THE PROTECTION SHEATH TO EXPAND THE FILTER BEFORE RELEASING IT BY PRESSING THE RELEASE BUTTON. ALSO, THE IFU WARN NOT TO ROTATE THE EXPANDED FILTER INSIDE THE VENA CAVA, AS DOING SO MAY COMPROMISE THE PERFORMANCE OF THE FILTER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE LOT PROVIDED E4504598 IS NOT A CELECT-PT DEVICE. THEREFORE, COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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

    DESCRPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN PLACING A CELECT PT JUGULAR FILTER, THE FILTER DIDN¿T DEPLOY ALL THE WAY. SEEMED LIKE A COUPLE OF THE ¿LEGS¿ WERE STUCK TOGETHER. THE DEVICE WAS SUCCESSFULLY REMOVED, AND NO FURTHER INTERVENTIONS WERE REQUIRED. A NEW FILTER WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME: THE DEVICE WAS SUCCESSFULLY REMOVED, AND NO FURTHER INTERVENTIONS WERE REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269237 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male