BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 17806787 · Received September 25, 2023

    Report

    Report Number
    3002808486-2023-00246
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    April 25, 2023
    Report Date
    September 26, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): K211874 . SUMMARY OF INVESTIGATIONAL FINDINGS: THERE WAS AN ISSUE WITH DEPLOYMENT. NO ADDITIONAL INFORMATION COULD BE OBTAINED, BUT ASSUMINGLY THE FILTER WOULD NOT RELEASE FROM THE JUGULAR INTRODUCER, WHY THE DEVICE WAS RETRIEVED WITHOUT ANY REPORTED HARM TO THE PATIENT. THE DEVICE WAS NOT RETURNED AND WITHOUT THE ACTUAL COMPLAINT DEVICE AND BASED ON THE VERY LIMITED INFORMATION PROVIDED, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DIFFICULTIES IN RELEASING THE FILTER FROM THE INTRODUCER. HOWEVER, APPROPRIATE ACTION HAS PREVIOUSLY BEEN INITIATED AND RELEVANT PERSONNEL HAVE BEEN NOTIFIED TO ADDRESS DIFFICULTIES IN RELEASING THE FILTER FROM THE JUGULAR INTRODUCER AND IS STILL ONGOING. 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: THERE WAS AN ISSUE WITH DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873031 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown