BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5534115 · Received March 30, 2016

    Report

    Report Number
    3002808486-2016-00151
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Report Date
    March 9, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. LOT# IS UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. PMA/510(K) #": AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K12057 OR K121629. DEVICE MANUFACTURE DATE: UNKNOWN AS LOT# IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: NO DEVICE, IMAGING STUDIES OR HOSPITAL OR MEDICAL RECORDS HAVE BEEN AVAILABLE. CONSEQUENTLY, BASED ON THE VERY LIMITED INFORMATION, IT IS NOT POSSIBLE TO COMMENT ON THE ALLEGED FILTER FRACTURE AND A ROOT CAUSE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THE ALLEGED FILTER FRACTURE CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. FILTER FRACTURE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS CATALOG # IS UNKNOWN 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K12057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PATIENT CAME IN TO SEE A DOCTOR WITH A COMPLAINT OF DISCOMFORT, AND AN IMAGE OF BROKEN STRUT / FILTER. PATIENT OUTCOME: UNKNOWN.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PATIENT CAME IN TO SEE A DOCTOR WITH A COMPLAINT OF DISCOMFORT, AND AN IMAGE OF BROKEN STRUT / FILTER. PATIENT OUTCOME: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192131 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other