BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 19236664 · Received May 3, 2024

    Report

    Report Number
    3002808486-2024-00075
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 27, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE UNDER PMA/510(K) K211875. INVESTIGATION IS STILL IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER WOULD NOT RELEASE FROM THE JUGULAR INTRODUCER AND WAS REMOVED WITH THE SHEATH. NO INFORMATION AS TO PATIENT OUTCOME THUS ASSUMING ANOTHER FILTER WAS SUCCESSFULLY PLACED. ALL DEVICE COMPONENTS WERE RETURNED AND NO BLOOD/BIOLOGICAL MATTER WAS NOTED ON ANY OF THEM. THE CELECT-PT FILTER WAS SEVERELY DAMAGED WITH CROSSED/TWISTED SECONDARY FILTER LEGS AND AN INVESTIGATION OF THE UNLOCKED JUGULAR INTRODUCER FOUND THE GRASPING HOOK STICKING INSIDE AND THE RELEASE BUTTON IMPOSSIBLE TO PRESS DOWN. OPENING THE HANDLE REVEALED A LOT OF HARDENED BLOOD INSIDE AND FOUND MINOR DAMAGES TO THE RED SAFETY BUTTON, WHICH MAY INDICATE THAT THE SYSTEM HAD NOT BEEN UNLOCKED DURING ATTEMPT(S) TO RELEASE THE FILTER FROM THE JUGULAR INTRODUCER. BASED ON THESE FINDINGS THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED CANNOT BE DETERMINED, BUT APPROPRIATE ACTIONS HAVE BEEN TAKEN TO ADDRESS DIFFICULTIES IN RELEASING THE FILTER FROM THE JUGULAR INTRODUCER. IT IS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE, 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 NONCONFORMING 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: RIGHT IJV AND LEFT POPLITIAL VIEN APPROCH. WE TRIED TO DEPLOY FILTER BUT COULD NOT DEPLOY, SO REMOVED PRODUCT IN SHEATH.

    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
    1420218 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4447045 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female