BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14335444 · Received May 9, 2022

    Report

    Report Number
    3002808486-2022-00296
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    March 6, 2022
    Report Date
    May 9, 2022
    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). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K211874 SUMMARY OF INVESTIGATIONAL FINDINGS: WHEN THE PHYSICIAN TRIED TO PLACE THE FILTER, IT WAS DIFFICULT TO DETACH/RELEASE THE FILTER BY PRESSING THE BUTTON. THE PHYSICIAN WAS ABLE TO PLACE THE FILTER BY APPLYING A SLIGHT PULLING TENSION WHILE PRESSING THE BUTTON. WHEN THE FILTER WAS RELEASED, THE PHYSICIAN FELT THAT THE FILTER ¿JUMPED¿ OFF THE JUGULAR INTRODUCER. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCE'S WERE DETECTED, THERE IS EVIDENCE THAT THE DHR 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. ACCORDING TO THE INSTRUCTION FOR USE 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. NO DEVICE WAS RETURNED, AND NO IMAGES WERE PROVIDED. WITH THE PROVIDED INFORMATION EXCESSIVE TENSION DURING DEPLOYMENT COULD PREVENT THE FILTER RELEASE AND MADE IT DIFFICULT TO GET THE FILTER OFF THE INTRODUCER BUT WITHOUT THE ACTUAL DEVICE RETURNED FOR EVALUATION THIS IS PURELY SPECULATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE APPROACH WAS GAINED FROM THE RIGHT JUGULAR VEIN. WHEN THE USER TRIED TO PLACE THE FILTER, IT WAS DIFFICULT TO DETACH/RELEASE THE FILTER BY PRESSING THE BUTTON, AND HE WAS ABLE TO PLACE THE FILTER BY APPLYING A SLIGHT PULLING TENSION WHILE PRESSING THE BUTTON. HOWEVER, COMPARED TO THE PREVIOUS PRODUCT, THE FILTER SEEMED TO JUMP WHEN IT WAS DETACHED/RELEASED FROM THE SYSTEM. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244234 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E4165446 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown