BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANGUARD BREAST MRI AUXILLIARY TABLE WITH 8CH

    MDR report key: 2661543 · Received July 13, 2012

    Report

    Report Number
    3005748597-2012-00001
    Event Type
    Other
    Date Received
    July 13, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 30, 2012
    Manufacturer
    SENTINELLE MEDICAL
    Product Code
    MOS
    PMA / PMN Number
    K060873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE INFORMED THAT A PATIENT RECEIVED A POSSIBLE HEMATOMA OR SILICONE LEAK DURING A BREAST MRI EXAM USING THE SENTINELLE BREAST MRI DEVICE. HOLOGIC APPLICATIONS PERSONNEL WAS ON SITE AT TIME OF THE EVENT. THERE WAS NO REPORTED FAILURE OF THE SENTINELLE BREAST MRI TABLE. TABLE AND ASSOCIATED PADDING WAS AVAILABLE AND FUNCTIONING AS EXPECTED. NO CASUAL RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD BE DETERMINED.

    Description of Event or Problem · 1

    (ONE) PATIENT WITH BILATERAL SILICONE BREAST IMPLANTS WAS POSITIONED PRONE ON THE SENTINELLE TABLE FOR A BREAST MRI EXAM. AFTER LYING PRONE ON THE TABLE FOR APPROXIMATELY 20 MINUTES, THE PATIENT COMPLAINED OF PAIN IN THE RIB AREA. PADDING WAS PLACED AROUND THE RIB AREA IN AN EFFORT TO REDUCE DISCOMFORT. UPON BEING PLACED IN THE MRI SCANNER, PATIENT COMPLAINED OF RIB PAIN AND EXAMINATION WAS DISCONTINUED. PATIENT WAS SEEN BY MEDICAL PROFESSIONAL AND SENT FOR X-RAY EXAM OF THE RIB AREA. ON 6/7/2012, SITE WAS CONTACTED BY DEVICE MANUFACTURER TO DETERMINE THE OUTCOME OF THE X-RAY TO ACCESS PATIENT IMPACT. IT WAS COMMUNICATED BY SITE REPRESENTATIVE THAT THERE WAS NO RIB FRACTURE. ON JUNE 21, 2012, SAME SITE REPRESENTATIVE WAS CONTACTED TO DETERMINE FURTHER PATIENT OUTCOME. DURING THIS COMMUNICATION, IT WAS REPORTED THAT ALTHOUGH THE PATIENT DID NOT SUSTAIN A RIB FRACTURE, A FOLLOW-UP ULTRASOUND NOTED AN AREA OF CONCERN FOR POSSIBLE HEMATOMA OR SILICONE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD BREAST MRI AUXILLIARY TABLE WITH 8CH COIL, MAGNETIC RESONANCE, SPECIALTY MOS SENTINELLE MEDICAL 4000341-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other