BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

    MDR report key: 546635 · Received September 28, 2004

    Report

    Report Number
    3003515897-2004-00009
    Event Type
    Injury
    Date Received
    September 28, 2004
    Date of Event
    August 17, 2004
    Report Date
    September 28, 2004
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT UNDERWENT A CORE NEEDLE BIOPSY USING THE CASSI ROTATIONAL CARE BIOPSY SYSTEM IN 2004. THE PHYSICIAN FELT CONFIDENT THAT HE WAS TARGETING A SUSPICIOUS LESION AS VISUALIZED ON ULTRASOUND. HE REPORTED GETTING CORES ABOUT 1/2 THE LENGTH THAT HE ANTICIPATED. HE TOOK 2 CORES. THE PATHOLOGY CAME BACK AS NORMAL BREAST PARENCHYMA. THE PHYSICIAN FELT THAT THIS DIAGNOSIS WAS DISCORDANT WITH THE VISUALIZED LESION AND PROCEEDED TO PERFORM AN OPEN SURGICAL BIOPSY TEN DAYS LATER. THE SURGICAL BIOPSY REPORT INDICATED THAT THERE WAS A HEMMORHAGIC BIOPSY CAVITY ADJACENT TO A LESION, WHICH WAS DIAGNOSED AS INFILTRATING DUCTAL CARCINOMA. THE PHYSICIAN REPORTED THIS SEQUENCE OF EVENTS TO THE SANARUS SALES REP IN 09/2004 EXPRESSING CONCERN THE CORE BIOPSY DIAGNOSIS WAS DISCORDANT WITH THE ULTRASOUND IMAGING, THUS, HE PROCEEDED TO AN OPEN SURGICAL BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM BIOPSY INSTRUMENT KNW SANARUS MEDICAL, INC. CS1000 CS04071

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention