BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS

    MDR report key: 5665628 · Received May 19, 2016

    Report

    Report Number
    3002808486-2016-00270
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 29, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-2-UNI-CELECT. DEVICE IS SIMILAR TO DEVICE WITH 510(K) K090140. SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION OF THE RETURNED PRODUCT FOUND THAT HARDENED CONTRAST AGENT HAS CAUSED THE FILTER TO GET STUCK, ALTHOUGH IT IS UNCONFIRMED WHETHER THIS OCCURRED DURING OR AFTER THE PROCEDURE. WITHOUT FURTHER INFORMATION IT IS NOT POSSIBLE TO INVESTIGATE ROOT CAUSE ANY FURTHER AND IT IS CONCLUDED THAT HARDENED CONTRAST CAUSED THAT THE FILTER GOT STUCK. IT IS NOTED THAT THE EVENT DID NOT HARM THE PATIENT AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #: IGTCFS-65-2-UNI-CELECT. DEVICE IS SIMILAR TO DEVICE WITH 510(K) K090140. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: THE SURGEON TRIED TO DEPLOY THE FILTER IN POSTCAVA MANY TIMES BUT FAILED TO DEPLOY. WITHDRAW THE FILTER AND REPLACE NEW ONE TO FINISH THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: THE SURGEON TRIED TO DEPLOY THE FILTER IN POSTCAVA MANY TIMES BUT FAILED TO DEPLOY. WITHDRAW THE FILTER AND REPLACE NEW ONE TO FINISH THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323253 COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002529219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other