BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5260199 · Received December 2, 2015

    Report

    Report Number
    3002808486-2015-00162
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUMMARY OF INVESTIGATION FINDINGS: NO IMAGING AND VERY LIMITED INFORMATION WAS PROVIDED, WHY IT IS NOT POSSIBLE TO COMMENT ON THE SECONDARY STRUT, WHICH FRACTURED DURING FILTER RETRIEVAL AND ON THE PAIN PATIENT EXPERIENCED DUE TO THIS OCCURRENCE. 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. FILTER FRACTURE OF THE WIRE IS AN UNCOMMON, BUT KNOWN RISK IN RELATION TO FILTER IMPLANT. HOWEVER, THE FILTER FRACTURE OCCURRED DURING RETRIEVAL AND NOT DURING THE IMPLANT 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. AS CATALOG# IS UNKNOWN IT COULD BE EITHER K06815, K073374, K090140, K112119, K121057 OR K12129. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: DIFFICULT CELECT FILTER REMOVAL. THE HOOK WAS EMBEDDED INTO THE WALL. FILTER WAS SNARED THRU THE STRUTS. THE HOOK ENDED UP BEING BENT UPON REMOVAL THRU THE SHEATH AND ONE SECONDARY STRUT FRACTURED. THE ENTIRE DEVICE CAME OUT TOGETHER. ALL THE PIECES WERE COUNTED AND ACCOUNTED FOR ON THE TABLE. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: DIFFICULT CELECT FILTER REMOVAL. THE HOOK WAS EMBEDDED INTO THE WALL. FILTER WAS SNARED THRU THE STRUTS. THE HOOK ENDED UP BEING BENT UPON REMOVAL THRU THE SHEATH AND ONE SECONDARY STRUT FRACTURED. THE ENTIRE DEVICE CAME OUT TOGETHER. ALL THE PIECES WERE COUNTED AND ACCOUNTED FOR ON THE TABLE. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792140 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other