BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6212090 · Received December 29, 2016

    Report

    Report Number
    3002808486-2016-01552
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K090140, K112119 OR K121057. SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS SOLELY BASED ON DESCRIPTION OF EVENT. NO PRODUCT WAS RETURNED AND NO IMAGE WAS PROVIDED. ACCORDING TO THE DESCRIPTION OF EVENT, THE "TIP WAS EMBEDDED WHICH WAS DISCOVERED UNDER RETRIEVAL OF THE FILTER." IT IS ASSUMED, THAT THE 'TIP' IS THE FILTER HOOK, AND THAT THE FILTER RETRIEVAL WAS DIFFICULT - BUT SUCCESSFUL. HOWEVER, BASED ON THE LIMITED INFORMATION PROVIDED, IT WOULD BE INAPPROPRIATE TO SPECULATE ON WHAT MAY OR MAY NOT HAVE LED TO THE REPORTED TIP EMBEDDED. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FROM THE PUBLISHED SCIENTIFIC LITERATURE FILTER TILT INSIDE IVC AND/OR EMBEDMENT OF FILTER LEGS OR FILTER HOOK IN THE IVC WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. 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.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: GUNTHER TULIP TIP WAS EMBEDDED WHICH WAS DISCOVERED UNDER RETRIEVAL OF THE FILTER. PATIENT OUTCOME: UNKNOWN.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: GUNTHER TULIP TIP WAS EMBEDDED WHICH WAS DISCOVERED UNDER RETRIEVAL OF THE FILTER. PATIENT OUTCOME: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861919 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1