BEUDAMED
    FDA Adverse Event Death Summary report: N

    1.0 MM X 497 MM RIGID PNEUMATIC PROBE

    MDR report key: 2894719 · Received January 3, 2013

    Report

    Report Number
    3005099803-2013-00004
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K012445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS FOR ONE OF ELEVEN BOSTON SCIENTIFIC CORPORATION (BSC) DEVICES USED DURING THIS PROCEDURE. PLEASE REFERENCE MDR# 3005099803-2012-06224 FOR THE PARENT DEVICE. IT WAS REPORTED TO BSC THAT A 1.0MM X 497MM RIGID ULTRASOUND PROBE WAS USED FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) WAS PERFORMED ON (B)(6) 2012. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED SUDDENLY. SHE BLED 'PROFUSELY.' THE PATIENT, WHOSE AGE WAS REPORTED TO BE 'IN HER 50'S,' HAD OTHER CO-MORBIDITIES (SPECIFICS UNKNOWN). SHE DIED THE FOLLOWING DAY, (B)(6) 2012. THERE WERE NO REPORTED DEFECTS OR MALFUNCTIONS WITH THE BSC DEVICE. SEVERAL ATTEMPTS WERE MADE BY DR (B)(4) OF BSC GLOBAL MEDICAL SAFETY TO SPEAK WITH THE SURGEON INVOLVED IN THE CASE, DR (B)(6). TODAY, (B)(6) 2013, DR (B)(6) RESPONDED THAT HE WOULD PROVIDE NO FURTHER INFORMATION REGARDING THIS CASE. THE PHYSICIAN HAS NOT RESPONDED TO SEVERAL REQUESTS FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494 1.0 MM X 497 MM RIGID PNEUMATIC PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC - SPENCER M0068407320

    Patients

    Seq Age Sex Outcome Treatment
    1 Death