BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VEN CAVA FILTER SET

    MDR report key: 1971777 · Received December 1, 2010

    Report

    Report Number
    3002808486-2011-00001
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 1, 2010
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) -DEVICE BREAKAGE. INSPECTION OF THE PRODUCT IS NOT POSSIBLE SINCE NO PRODUCT IS RETURNED. A SEARCH SHOWED NO COMMENTS ON WORK ORDER (B)(4) AND NO OTHER COMPLAINTS REC'D ON THIS LOT #. EVAL OF THIS COMPLAINT IS BASED ON THE DESCRIPTION ONLY. THE FILTER WAS PLACED FROM JUGULAR APPROACH ACCORDING TO CLARIFYING ANSWER FROM THE DISTRICT MANAGER. BASED ON THE LIMITED INFO WCE IS NOT ABLE TO DETERMINE THE EXACT ROOT CAUSE FOR THIS INCIDENT. WCE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. SINCE NO OTHER COMPLAINT IS REC'D ON THIS LOT NUMBER, NOTHING FURTHER IS INITIATED AT THIS TIME. ADD'L INFO FROM THE USER FACILITY REPORT: COOK CELECT VENA CAVA FILTER, VENA CAVA FILTER, (B)(4).

    Description of Event or Problem · 1

    PT WAS UNDERGOING A VENA CAVA FILTER PLACEMENT. THE FILTER SPONTANEOUSLY DEPLOYED FROM ITS ATTACHMENT DEVICE AND DID NOT GO TO THE INTENDED LOCATION. A SNARE WAS UTILIZED BUT GOT CAUGHT IN THE FILTER LEGS AND COULD NOT BE FREED AND WAS CUT WITH SURGICAL WIRE CUTTERS. ON (B)(6) 2010, ADDED THE ATTACHMENT FOR THE CLARIFICATION THAT THE FILTER WAS PLACED JUGULAR AND IT IS STILL IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT NAVALIGN JUGULAR & FEMORAL VEN CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE NA E2665679

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other