BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20198524 · Received September 12, 2024

    Report

    Report Number
    3002808486-2024-00182
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 8, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS GÜNTHER TULIP VENA CAVA FILTER G4) PMA/510(K): K233680. 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). ADDITIONAL INFORMATION RECEIVED STATES, THAT NO LEG BROKE OF THE FILTER. THE FILTER WAS LEFT IN PLACE. THERE WAS AN ISSUE WITH THE GLIDEWIRE, WHICH IS NOT A COOK DEVICE. 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: I HAD A TULIP PUT IN (B)(6) 2024 AFTER A PULMONARY EMBOLISM. ATTEMPT TO REMOVE THE FILTER ON (B)(6) 2024. IT WAS NOT SUCCESSFUL AND ONE OF THE LEGS BROKE OFF. IT WAS SNARED AND RETRIEVED. PATIENT OUTCOME: PARTIAL TULIP REMAINING IN MY INFERIOR VENA CAVA.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 16SEP2024: IT IS CONFIRMED THAT THE FILTER WAS LEFT IN PLACE AND NO LEG BROKE OFF. IT WAS THE GLIDEWIRE THAT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515013 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other