BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5507141 · Received March 17, 2016

    Report

    Report Number
    3002808486-2016-00139
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Report Date
    March 4, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. SUMMARY OF INVESTIGATIONAL FINDINGS: SINCE NO PLACEMENT IMAGES HAVE BEEN PROVIDED THE REPORTED MIGRATION CANNOT BE CONFIRMED AND DUE TO VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO COMMENT ON THE REPORTED ABDOMINAL PAIN, WHICH PATIENT EXPERIENCED. HOWEVER, THE FILTER DEMONSTRATED APPROX. 46° RIGHTWARD TILT. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. LOT# AND RPN ARE UNKNOWN, BUT THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER - IF NOT TILTED - WOULD PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: THE IVC FILTER MIGRATED. PATIENT OUTCOME: IT IS UNKNOWN IF THE PATIENT UNDERWENT ANY ADDITIONAL PROCEDURES OR IF THERE HAVE BEEN ANY ADVERSE EFFECTS AT THIS TIME. INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: THE IVC FILTER MIGRATED. PATIENT OUTCOME: IT IS UNKNOWN IF THE PATIENT UNDERWENT ANY ADDITIONAL PROCEDURES OR IF THERE HAVE BEEN ANY ADVERSE EFFECTS AT THIS TIME. INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165728 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other