BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 20319780 · Received September 27, 2024

    Report

    Report Number
    3002808486-2024-00196
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 27, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3) OCCUPATION: IR MANAGER G4) PMA/510(K): K233680 AFTER INVESTIGATION THE EVENT IS CONSIDERED REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: WHILE THEY WERE TRYING TO DEPLOY THE FILTER, THE ARMS OPENED, BUT THE LEGS DID NOT. ¿LIKE THEY WERE CAUGHT ON EACH OTHER¿. THEY HAD TO RETRIEVE IT AND PLACE A NEW FILTER. ONCE RETRIEVED, WHEN THEY PULLED IT OUT OF THE SHEATH, THE LEGS OF THE FILTER OPENED. NO DEVICE WAS RETURNED. THEREFORE, BASED ON THE INFORMATION PROVIDED ONLY IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY HAVE NOT 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. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCE'S WERE PROPERLY DISPOSITIONED BEFORE RELEASE AND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHILE THE PHYSICIANS WERE TRYING TO DEPLOY THE FILTER, THE ARMS OPENED UP BUT THE LEGS DID NOT. LIKE THEY WERE CAUGHT ON EACH OTHER. THE PHYSICIANS HAD TO RETRIEVE IT AND PLACE A NEW FILTER. ONCE RETRIEVED, WHEN THEY PULLED IT OUT OF THE SHEATH, THE LEGS OF THE FILTER OPENED. PATIENT OUTCOME THE CASE WAS ABLE TO BE COMPLETED AND FURTHER INTERVENTIONS WERE NOT NEEDED BECAUSE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663492 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4521353 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female