BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET

    MDR report key: 3862842 · Received May 22, 2014

    Report

    Report Number
    3002808486-2014-00017
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN AS INFORMATION WAS NOT PROVIDED BY REPORTER. UNKNOWN AS LOT# IS UNKNOWN. AS NO DEVICE, IMAGING STUDIES OR HOSPITAL OR MEDICAL RECORDS HAVE BEEN AVAILABLE, THE INVESTIGATION IS LIMITED TO THE ALLEGATIONS IN THE EVENT DESCRIPTION. CONSEQUENTLY, BASED ON VERY LIMITED INFORMATION IT IS DIFFICULT TO COMMENT ON THE ALLEGED FILTER FRACTURE AND MIGRATION. INSTRUCTIONS FOR USE LIST DAMAGE TO THE VENA CAVA, AND VENA CAVA PERFORATION AS POTENTIAL ADVERSE EVENTS. SUCH EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. CATALOG #KNOWN, HOWEVER LOT# WAS NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. THE EXACT ROOT CAUSE FOR THE ALLEGED FILTER FRACTURE CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. MONITORING OF SIMILAR REPORTS WILL CONTINUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT'S HUSBAND THAT THE CELECT FILTER HAS FRACTURED AND MIGRATED SOME TIME AFTER PLACEMENT. ACCORDING TO THE INFORMATION RECEIVED, ANOTHER PHYSICIAN REMOVED MOST OF THE FRACTURED FILTER. FURTHER DETAILS ARE UNKNOWN AT THIS TIME. PART OF THE FRACTURED FILTER HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306746 NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other