BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 20381676 · Received October 7, 2024

    Report

    Report Number
    3002808486-2024-00212
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    July 31, 2024
    Report Date
    October 7, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) PMA/510(K): K233680. AFTER INVESTIGATION, THIS PR# IS CONSIDERED REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: DURING ADVANCEMENT FROM FEMORAL APPROACH THE CELECT-PT FILTER PERFORATED THE SHEATH AND WAS LIKELY DEPLOYED IN ILIAC VEIN. THE FILTER WAS REMOVED AT A DIFFERENT FACILITY. NO DEVICE WAS RETURNED FOR ANALYSIS, BUT A PHOTO PROVIDED SHOWED THE FEMORAL INTRODUCER WITHOUT THE FILTER PENETRATING FROM A SEVERE KINK CLOSE TO THE DISTAL TIP OF THE BLUE SHEATH. AS REPORTED TORTUOUS ANATOMY CAUSED THE SHEATH TO KINK AND RESULTED IN THE FILTER TO PENETRATE THE SHEATH, AS THE FILTER HOOK MAY BE PRONE TO EXCEED THE SHEATH WALL IF FORCEFULLY ADVANCED THROUGH A KINKED SHEATH. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT 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 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: A FEMALE PATIENT OF UNDISCLOSED AGE WAS TO UNDERGO A PROCEDURE TO REPAIR A HIP FRACTURE, AND THE PHYSICIAN WAD PLACING A FILTER AS A SUBSEQUENT PROCEDURE. THE PHYSICIAN GAINED ACCESS IN THE LEFT FEMORAL VEIN. WHILE ADVANCING THE FILTER PERFORATED THE SHEATH. THE NURSE MANAGER BELIEVES IT DEPLOYED IN THE ILIAC VEIN, ALTHOUGH THERE ARE NO IMAGES TO CONFIRM. THE PHYSICIAN STATED THE SHEATH MAY HAVE GOT CAUGHT ON THE ILIAC VEIN. THE PATIENT WAS TRANSFERRED TO A SISTER FACILITY TO AN INTERVENTIONAL RADIOLOGIST. INFORMATION RECEIVED ON 28AUG2024. THE INTRODUCER BECAME KINKED CAUSING THE FILTER TO PROTRUDE OUT THROUGH THE SIDE OF THE SHEATH AND CAUSING MISPOSITIONING OF THE FILTER IN THE LEFT ILIAC VEIN. TORTUOUS INFERIOR VENA CAVA WITH THE RIGHT RENAL COMING OFF AT A VERY ACUTE ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538846 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34505 E4521289 10827002345055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention