BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 18621195 · Received February 1, 2024

    Report

    Report Number
    3002808486-2024-00020
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 20, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3) OCCUPATION: INVENTORY MANAGER G4) PMA/510(K): K211874 INVESTIGATION IS STILL IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS (B)(4) IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER RELEASE THE TULIP FILTER WAS CROOKED/TILTED. THE FILTER WAS RETRIEVED AND ANOTHER FILTER WAS SUCCESSFULLY PLACED. THE TULIP FILTER NOR THE INTRODUCER SYSTEM WAS RETURNED FOR ANALYSIS AND NO IMAGING COULD BE OBTAINED. THEREFORE, BASED ON THE INFORMATION PROVIDED ONLY IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER TO TILT DURING PLACEMENT. THE INSTRUCTIONS FOR USE SUPPLIED WITH ANY TULIP FILTER SPECIFY STEP-BY-STEP HOW TO VERIFY CORRECT FILTER POSITION BEFORE RELEASING THE FILTER FROM THE INTRODUCER SYSTEM BY PRESSING THE RELEASE BUTTON. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. 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: DURING PLACEMENT THEY WERE ABLE TO DETACH, BUT WHEN IT DEPLOYED IT WAS CROOKED. THAT DEVICE WAS RETRIEVED WITH NO ISSUES AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

    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
    382878 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown