BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    MDR report key: 2020718 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00988
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K955396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED AS THE BATCH NUMBER WAS UNKNOWN. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DEVICE WAS NOT IMPLANTED ACCORDING TO THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A FILTER IMPLANTATION PROCEDURE, THE FILTER WAS FOUND TO BE IMPLANTED INCORRECTLY. VASCULAR ACCESS WAS OBTAINED VIA A JUGULAR VEIN. THE STAINLESS STEEL GREENFIELD VENA CAVA FILTER WAS IMPLANTED IN AN UNSPECIFIED LOCATION. POST PROCEDURE, THE PHYSICIAN NOTED THAT THE FILTER WAS IMPLANTED UPSIDE DOWN. THE PHYSICIAN HAD IMPLANTED A GREENFIELD FILTER WITH A FEMORAL ACCESS SYSTEM DESIGN WHILE UTILIZING A JUGULAR APPROACH. THE GREENFIELD FILTER REMAINS IMPLANTED IN ITS ORIGINAL LOCATION AND NO FURTHER TREATMENT IS PLANNED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001505010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other