BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD¿

    MDR report key: 3002384 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01440
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DTK
    PMA / PMN Number
    K964284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. 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 VENA CAVA FILTER PLACEMENT PROCEDURE, DEPLOYMENT ISSUES OCCURRED. THE PHYSICIAN ATTEMPTED TO DEPLOY A 12F GREENFIELD STAINLESS STEEL FILTER IN THE VENA CAVA. UPON DEPLOYMENT, THE LEGS OF THE FILTER DID NOT OPEN. A SECOND FILTER WAS PLACED AND DEPLOYED IMMEDIATELY ABOVE THE FIRST FILTER WITHOUT ISSUES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104904 GREENFIELD¿ FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - MAPLE GROVE M001504000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention