BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6696347 · Received July 10, 2017

    Report

    Report Number
    3002808486-2017-01436
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    June 14, 2017
    Report Date
    June 15, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). D4) CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K12162. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN HAD A DIFFICULT RETRIEVAL ON (B)(6) 2017 IN THE OPERATING ROOM. THE CELECT FILTER MIGRATED WITH LEGS THAT MIGRATED INTO THE HEART. THE PHYSICIAN WENT IN PERCUTANEOUSLY AND WAS ABLE TO REMOVE THE FILTER AND LEGS. UNKNOWN TIMELINE OF IMPLANT HOWEVER WAS IMPLANTED APPROXIMATELY 2 YEARS PRIOR. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS SOLELY BASED ON DESCRIPTION OF EVENT, IT IS ASSUMED THAT THE FILTER MIGRATED DURING THE RETRIEVAL PROCEDURE. HOWEVER, GIVEN THE LIMITED INFORMATION PROVIDED, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE LED TO THE REPORTED MIGRATION OF THE FILTER INTO THE HEART. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478187 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening