BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 20331974 · Received September 30, 2024

    Report

    Report Number
    3002808486-2024-00201
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 30, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. EVENT FOUND REPORTABLE AFTER INVESTIGATION. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K233680. SUMMARY OF INVESTIGATIONAL FINDINGS: THE TULIP FILTER WOULD NOT RELEASE FROM THE JUGULAR INTRODUCER. THEREFORE, IT WAS REMOVED AND ANOTHER FILTER WAS SUCCESSFULLY PLACED. THE DILATOR AND THE JUGULAR INTRODUCER WITH LOADED TULIP FILTER INSIDE THE INTRODUCER SHEATH WERE RETURNED. AN INVESTIGATION OF THE COMPONENTS REVEALED NO NON-CONFORMANCES AND THE FILTER COULD BE ADVANCED THROUGH THE SHEATH AND RELEASED FROM THE UNLOCKED JUGULAR INTRODUCER AS INTENDED WHEN PRESSING THE RELEASE BUTTON. BASED ON THESE FINDINGS THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED DURING ATTEMPT TO RELEASE THE FILTER FROM THE JUGULAR INTRODUCER CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE SPECIFY STEP-BY-STEP HOW TO PLACE AND RELEASE THE FILTER BY PUSHING THE RELEASE BUTTON COMPLETELY AND STATE THAT EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. 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 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: THE INFERIOR VENA CAVA WAS APPROACHED FROM THE RIGHT JUGULAR VEIN. AFTER DETERMINING THE PLACEMENT POSITION JUST BELOW THE RENAL VEIN, THE PHYSICIAN DEPLOYED THE FILTER AND ATTEMPTED TO RELEASE IT, BUT THE FILTER WAS NOT RELEASED, SO HE COVERED THE FILTER WITH THE SHEATH AGAIN AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF A TEMPORARY FILTER FROM ANOTHER MANUFACTURER. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587904 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E4559056 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown