BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 20381694 · Received October 7, 2024

    Report

    Report Number
    3002808486-2024-00209
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 20, 2024
    Report Date
    December 6, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 PMA/510(K): K233680. INVESTIGATION IS STILL IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: WHEN ADVANCING THE CATHETER, THE FILTER DEPLOYED ON ITS OWN. THE FILTER WAS REMOVED WITH A RETRIEVAL KIT AND ANOTHER FILTER WAS SUCCESSFULLY PLACED, THUS ASSUMING THE FILTER WAS PLACED IN AN INCORRECT POSITION. NO ADDITIONAL INFORMATION COULD BE OBTAINED, BUT SINCE THE FILTER WAS RETRIEVED BY A RETRIEVAL KIT AND SINCE NO INFORMATION AS TO RELOAD FROM FEMORAL TO JUGULAR INTRODUCER PRIOR TO USE, IT IS ASSUMED THAT THE FILTER WAS ADVANCED FROM FEMORAL APPROACH. NO DEVICE WAS RETURNED TO ASSIST THE INVESTIGATION AND WITHOUT THE ACTUAL COMPLAINT DEVICE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER TO DEPLOY ON ITS OWN. THE FEMORAL INTRODUCER IS SUPPLIED IN A LOCKED CONDITION AND MUST BE UNLOCKED BEFORE THE FILTER CAN BE DEPLOYED BY PRESSING THE RELEASE BUTTON. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE SPECIFY STEP-BY-STEP HOW TO ADVANCE THE INTRODUCER WITH FILTER AND VERIFY CORRECT FILTER POSITION BEFORE UNLOCKING THE INTRODUCER AND PRESSING THE RELEASE BUTTON FOR FILTER DEPLOYMENT. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS 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 PRODUCT EXISTS IN HOUSE OR IN FIELD. 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: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN INFERIOR VENA CAVA (IVC) FILTER PLACEMENT PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN UNISET, WAS USED. WHEN ADVANCING THE CATHETER, THE FILTER DEPLOYED ON ITS OWN. THE PHYSICIAN HAD TO GO IN WITH A RETRIEVAL KIT TO REMOVE THE FILTER AND FINALLY USED ANOTHER FILTER WHICH WORKED.

    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
    2539800 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34505 E4581768 10827002345055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention