BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 4077274 · Received August 21, 2014

    Report

    Report Number
    1820334-2014-00403
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 28, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 510(K): MOST LIKELY K072240 OR K043509. CANNOT KNOW FOR SURE AS CATALOG NUMBER IS UNKNOWN AS NOT PROVIDED BY THE REPORTER. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AFTER IMPLANT OF A GUNTHER TULIP FILTER SOMETIME IN 2005, A PATIENT UNDERWENT ATTEMPTED FILTER RETRIEVAL AT HOSPITAL 1 WHICH WAS UNSUCCESSFUL. THE PATIENT THEN UNDERWENT A GUNTHER TULIP FILTER RETRIEVAL ON (B)(6) 2014 AT HOSPITAL 2 AND WAS REMOVED SUCCESSFULLY. THE FILTER HAD FRACTURED AND HAD TO BE REMOVED, THE SMALL WIRES X 2 FRACTURED. THE COOK REP IS TRYING TO OBTAIN MORE INFORMATION. NO PATIENT OUTCOME HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504620 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK