BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOMMOSITE CAVITY EVALUATION DEVICE

    MDR report key: 2948070 · Received June 26, 2008

    Report

    Report Number
    1222780-2008-00071
    Event Type
    Injury
    Date Received
    June 26, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 28, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    JAQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USER (IFU) UNDER THE INTENDED USE/INDICATIONS SECTION AND THE INSTRUCTIONS FOR USE SECTION: THE MAMMOSITE CAVITY EVALUATION DEVICE WILL BE USED AS A DISPOSABLE SURGICAL TOOL FOR DETERMINING WHICH MAMMOSITE BALLOON SHOULD BE IMPLANTED INTO THE LUMPECTOMY CAVITY. PLACEMENT OF THE MAMMOSITE CED MAY BE ACCOMPLISHED THROUGH A VARIETY OF TECHNIQUES. IMPLANTATION OF THIS DEVICE IS AT THE DISCRETION OF THE PHYSICIAN. ONCE THE LUMPECTOMY CAVITY HAS BEEN ASSESSED AND THE APPROPRIATE MAMMOSITE RTS BALLOON SIZE HAS BEEN IDENTIFIED, FULLY DEFLATE AND REMOVE THE MAMMOSITE CED FROM THE LUMPECTOMY CAVITY AND DISPOSE OF AS MEDICAL WASTE. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT A MAMMOSITE CAVITY EVALUATION DEVICE (CED) WAS PLACED DURING A LUMPECTOMY PROCEDURE ON APPROXIMATELY (B)(6) 2007. ONE WEEK AFTER PLACEMENT, THE PATIENT WAS SCHEDULED TO HAVE THE MAMMOSITE CED REPLACED WITH A MAMMOSITE RADIATION THERAPY SYSTEM. UPON THE ATTEMPT TO REMOVE THE MAMMOSITE CED, THE "TAIL BROKE OFF AND LEFT [THE] BALLOON REMAINING IN THE PATIENT'S BREAST. THE CED WAS DEFLATED, THE TRACK WAS OPENED UP PRIOR TO EXPLANT WITH A HEMOSTATE AND TROCAR TO EXPAND TRACK, AND A STIFF STYLET WAS USED FOR RIGIDITY." THE PHYSICIAN WAS STILL "UNABLE TO REMOVE [THE] REMAINING BALLOON IN [THE] BREAST AFTER SEVERAL ATTEMPTS." THE PATIENT WAS THEN SENT TO THE OPERATING ROOM FOR REMOVAL OF THE MAMMOSITE CED DEVICE AND THE PLACEMENT OF THE MAMMOSITE RADIATION THERAPY SYSTEM. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2006. THE PHYSICIAN INDICATED "EVERYTHING WENT WELL IN OPERATING ROOM WITH NO PROBLEMS WITH THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOMMOSITE CAVITY EVALUATION DEVICE JAQ CYTYC SURGICAL PRODUCTS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention