BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS VISICA 2 ICE PROBE

    MDR report key: 1032153 · Received April 21, 2008

    Report

    Report Number
    3003515897-2008-00002
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    December 11, 2007
    Report Date
    April 21, 2008
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU STATES: "FOLLOWING THE PROCEDURE HOLD COMPRESSION UNTIL HEMOSTASIS IS ACHIEVED." THE IFU ALSO STATES "POTENTIAL COMPLICATIONS OF CORE BIOPSY ARE SITE-SPECIFIC AND MAY INCLUDE HEMATOMA, HEMORRHAGE, INFECTION, ADJACENT TISSUE OR ORGAN INJURY, AND PAIN." DEVICE CODE: DEVICE WAS DISCARDED. NO ANALYSIS WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE VISCIA 2 ICE PROBE TO CRYOABLATE A BREAST FIBROADENOMA. LATER THAT DAY, THE PT HAD SOME BLEEDING FROM THE INSERTION SITE AND HELD PRESSURE TO STOP THE BLEEDING. THE BLEEDING CONTINUED AND THE PT CALLED THE OFFICE AND WAS TOLD TO COME IN TO SEE THE PHYSICIAN. THE PT MENTIONED TO THE NURSE AT THE OFFICE THAT NO ONE HELD PRESSURE ON THE INSERTION SITE AFTER THE PROCEDURE WAS COMPLETED. WHEN THE PT ARRIVED AT THE OFFICE, THE PHYSICIAN APPLIED DERMABOND TO THE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA 2 ICE PROBE VISICA 2 ICE PROBE GEH SANARUS MEDICAL, INC. VP0600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention