BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3830735 · Received May 7, 2014

    Report

    Report Number
    3002808486-2014-00013
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 11, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNK BUT REFERRED TO AS "COOK CELECT" BY RPTR. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: PT WAS BROUGHT TO THE (B)(6), REFERRED BY HIS PHYSICIAN FROM (B)(6). FILTER LEGS AND HOOK PENETRATED THE IVC WALL. TRADITIONAL RETRIEVAL METHODS COULD NOT BE MADE DUE TO PENETRATION. A 14 FR. SHEATH AND ALLIGATOR JAW WAS USED TO HOOK AND SHEATH THE FILTER FOR SUCCESSFUL RETRIEVAL. MULTIPLE FRACTIONS IN THE LEGS OF THE FILTER. ONE LEG FRACTURED IN PULMONARY ARTERY, AND WAS SUCCESSFULLY RETRIEVED WITH A SNARE. A SECOND FRACTURED LEG IN THE HEPATIC VEIN WAS RETRIEVED WITH A SNARE. PT OUTCOME: ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274900 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR