BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14336369 · Received May 9, 2022

    Report

    Report Number
    3002808486-2022-00299
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 9, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# PR(B)(4). PMA/510(K): K211875. SUMMARY OF INVESTIGATIONAL FINDINGS: UPON DEPLOYMENT, THE LEGS OF THE FILTER DIDN'T OPEN INITIALLY. THE PHYSICIAN HAD TO USE A SNARE AFTER DEPLOYMENT TO REMOVE THE FILTER. WHEN THE FILTER WAS SNARED AND PULLED IT STARTED TO OPEN THE LEGS AND AFTER THAT EVERYTHING WAS FINE. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. ACCORDING TO THE INSTRUCTION FOR USE POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. NO IMAGES WERE PROVIDED, OR THE DEVICE RETURNED. WITHOUT ANY IMAGES OR THE DEVICE RETURNED IT WOULD BE INAPPROPRIATE TO SPECULATE WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER NOT TO EXPAND. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT, THE LEGS OF THE FILTER DIDN'T OPEN INITIALLY. THE LEGS DID EVENTUALLY OPEN. THEY HAD TO, AFTER DEPLOYMENT, SNARE THE DEVICE TO REMOVE IT. WHEN THEY SNARED IT AND STARTED TO PULL IT THE LEGS OPENED AND AFTER THAT EVERYTHING WAS FINE. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244281 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4148254 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown