BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5045127 · Received September 1, 2015

    Report

    Report Number
    3002808486-2015-00104
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Report Date
    August 8, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. SUMMARY OF INVESTIGATION FINDINGS: IMAGING CONFIRM THAT A PRIMARY FILTER LEG HAS FRACTURED AT ITS MIDPOINT. FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. LOT NO 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 DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE PATIENT PRESENTED WITH DVT IN THE LOWER EXTREMITY. FLUOROSCOPY IMAGING WAS TAKEN AND ONE OF THE PRIMARY LEGS OF THE CELECT FILTER WAS NOTED TO HAVE BROKEN OFF. THE PATIENT IS NOT SYMPTOMATIC AND THE FILTER REMAINS IN THE PATIENT. PATIENT OUTCOME: IT IS UNKNOWN IF ANY ACTIONS WILL BE TAKEN TO REMOVE THE FILTER AT THIS TIME. THIS INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE PATIENT PRESENTED WITH DVT IN THE LOWER EXTREMITY. FLUOROSCOPY IMAGING WAS TAKEN AND ONE OF THE PRIMARY LEGS OF THE CELECT FILTER WAS NOTED TO HAVE BROKEN OFF. THE PATIENT IS NOT SYMPTOMATIC AND THE FILTER REMAINS IN THE PATIENT. PATIENT OUTCOME: IT IS UNKNOWN IF ANY ACTIONS WILL BE TAKEN TO REMOVE THE FILTER AT THIS TIME. THIS INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578936 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1