BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENFIELD¿

    MDR report key: 3000184 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01446
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K901659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A DEPLOYMENT ISSUE OCCURED. THE INTENDED LOCATION FOR TREATMENT WAS THE VENA CAVA. A 12 FR GREENFIELD FILTER WAS SUCCESSFULLY ADVANCED TO THE TARGET LOCATION. THE FILTER WAS DEPLOYED, HOWEVER UPON DEPLOYMENT THREE OF FOUR LEGS WERE BUNCHED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103601 GREENFIELD¿ FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001503010

    Patients

    Seq Age Sex Outcome Treatment
    1