BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS

    MDR report key: 5895770 · Received August 23, 2016

    Report

    Report Number
    3002808486-2016-00926
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    July 22, 2013
    Report Date
    July 25, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-2-UNI-CELECT. SIMILAR TO DEVICE UNDER 510(K) K090140. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: NO PRODUCT, PHOTOS OR IMAGING RECEIVED TO SUPPORT THE INVESTIGATION. BASED ON THE VERY LIMITED INFORMATION IT IS NOT POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THE EVENT COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: COULD NOT FLUSH THE SIDE PORT. PROCEEDED WITH CASE AND NO FURTHER PROBLEMS. PATIENT OUTCOME: PRIOR TO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549019 COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002529219

    Patients

    Seq Age Sex Outcome Treatment
    1