BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 488017 · Received October 7, 2003

    Report

    Report Number
    3003515897-2003-00004
    Event Type
    Injury
    Date Received
    October 7, 2003
    Date of Event
    September 19, 2003
    Report Date
    October 4, 2003
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED CRYOBLATION TREATMENT OF A LARGE FIBROADENOMA WITH THE VISICA TREATMENT SYSTEM. THE LESION WAS APPROXIMATELY 1.5 CM FROM THE SKIN'S SURFACE. THE PHYSICIAN HAD TROUBLE VISUALIZING THE LESION ON THE SONOSITE ULTRASOUND SYSTEM SHE WAS USING, AS THE SCREEN IS LIMITED TO A FIELD OF VIEW OF 4 CM. THE DOCTOR MADE ATTEMPTS TO PLACE PROBE CENTRALLY FOR ABOUT 10 MINUTES. DURING THIS EFFORT TO PLACE THE PROBE, THE DOCTOR PIERCED A VESSEL WITH A VISICA PROBE AND THE PT BEGAN BLEEDING. THE PHYSICIAN BELIEVED THAT SHE PIERCED A VEIN, BASED UPON THE PRESENCE OF "DARK" BLOOD. THE DOCTOR APPLIED COMPRESSION TO THE AREA AND DID NOT PROCEED WITH THE VISICA PROCEDURE. THE PHYSICIAN REPORTED THAT SHE BELIEVED THE PATIENT HAD DILATED BLOOD VESSELS DUE TO THEIR CONDITION AND THAT THIS SORT OF BLEEDING COULD BE ANTICIPATED. THE PATIENT REPORTED BRUISING ON THE BREAST. DR SAW THE PT ONE WEEK LATER IN 9/2003 FOR AN OPEN EXCISIONAL BIOPSY TO REMOVE THE FIBROADENOMA. DR REPORTED IN 10/2003 THAT THE PATIENT HAD NO HEMATOMA FROM THE PREVIOUS PROCEDURE AND HAD MILD ECCHYMOSIS. THE FIBROADENOMA WAS OVER 5 CM IN SIZE. THE EXCISION WAS UNREMARKABLE AND THE PATIENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VP0500 V030801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention