BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    MDR report key: 18892642 · Received March 13, 2024

    Report

    Report Number
    3002808486-2024-00044
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Report Date
    March 13, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF (B)(4) BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS EVENT BECAME REPORTABLE AFTER INVESTIGATION 05MAR2024. G4)PMA/510(K) K211874 SUMMARY OF INVESTIGATIONAL FINDINGS: RESISTANCE WAS FELT, WHEN ATTEMPTING TO UNSHEATH THE FILTER. THE DEVICE WAS REMOVED AND ANOTHER FILTER WAS SUCCESSFULLY PLACED WITHOUT REPORTED HARM TO THE PATIENT. THE JUGULAR INTRODUCER AND THE FEMORAL INTRODUCER WITH LOADED FILTER WERE RETURNED. THE FEMORAL INTRODUCER WAS STILL LOCKED, AS THE SAFETY BUTTON WAS NOT PRESSED, BUT IT COULD EASILY BE PRESSED/UNLOCKED AND THE SYSTEM WORKED AS INTENDED. BASED ON THESE FINDINGS THE REASON FOR THE DIFFICULTIES IN UNSHEATHING THE FILTER CANNOT BE DETERMINED, AS THE SHEATH WAS NOT RETURNED. DURING MANUFACTURING THE FEMORAL INTRODUCER IS ADVANCED THROUGH THE SHEATH AND THE SHEATH IS DESTROYED IN CASE OF RESISTANCE. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, THERE IS EVIDENCE THAT THE DEVICE HISTORY RECORD 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DOCTOR WAS TRYING TO PERFORM AN INFERIOR VENA CAVA FILTER PLACEMENT. PREPPED DEVICE PER PROTOCOL. FOUND THAT WHEN HE TRIED TO UNSHEATH FILTER, THERE WAS RESISTANCE SO STOPPED AND REMOVED EVERYTHING FROM PATIENT. NO HARM TO PATIENT. A NEW FILTER WAS OPENED AND PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018253 GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4457215 10827002529189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown