BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD 12FR SS VENA CAVA FILTER

    MDR report key: 2940799 · Received December 15, 2006

    Report

    Report Number
    6000118-2006-00086
    Event Type
    Injury
    Date Received
    December 15, 2006
    Date of Event
    November 15, 2006
    Report Date
    November 16, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    PMA / PMN Number
    K955396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENA CAVA FILTER PLACEMENT PROCEDURE, FILTER PLACEMENT DIFFICULTY OCCURRED. ACCORDING TO THE CUSTOMER THE "FILTER FELL OFF OF THE TIP WHILE STILL INSIDE OF THE SHEATH, INSIDE THE FEMORAL ARTERY. ABLE TO REMOVE WITHOUT CAUSING HARM TO PT. HAD TO USE A JUGULAR FILTER TO COMPLETE PROCEDURE, SAME PRODUCT NOT AVAILABLE." NO PT INJURIES WERE REPORTED. PT CONDITION IS REPORTED AS "FINE". ADD'L INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD 12FR SS VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC NA 8562887

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention