BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY FILTER SYSTEM

    MDR report key: 2033903 · Received March 18, 2011

    Report

    Report Number
    2020394-2011-00053
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED IN THE PATIENT. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST FILTER IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND SHORTNESS OF BREATH. CT IMAGING DEMONSTRATED TWO FILTER LIMBS HAD DETACHED FROM THE FILTER AND MOVED INTO THE HEART. AN ATTEMPT TO REMOVE THE FILTER WAS PERFORMED USING A RECOVERY CONE, HOWEVER, THE PHYSICIAN WAS UNABLE TO ALIGN THE CONE OVER THE APEX TO RETRIEVE THE FILTER. THERE WAS NO ATTEMPT TO RETRIEVE THE DETACHED COMPONENTS FROM THE HEART. NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening