BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENFIELD 12FR SS VENA CAVA FILTER

    MDR report key: 1011675 · Received March 10, 2008

    Report

    Report Number
    2134265-2008-00712
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    PMA / PMN Number
    K955396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMLPAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODCUT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A GREENFIELD FILTER PLACEMENT PROCEDURE, THE FILTER DEPLOYED DURING PREP. DURING PREPARATION OF THE 12FR GREENFIELD FILTER, THE PYSICIAN FLUSHED THE DEVICE PRIOR TO REMOVING THE PROTECTIVE SLEEVE. UPON WITHDRAWING THE PROTECTIVE SLEEVE AND REMOVING THE END CAP, THE FILTER "POPPED" ENTIRELY OUT OF THE CARRIER ALONG WITH THE WIRE. IT WAS NOTED THAT THERE WAS NO MANIPULATION OF THE RELEASE HANDLE AND THAT IT REMAINED IN THE LOCKED POSITION. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S STATUS WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD 12FR SS VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVERTER DTK BOSTON SCIENTIFIC NA 11344412

    Patients

    Seq Age Sex Outcome Treatment
    1