BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISICA 2 ICE PROBE

    MDR report key: 5727716 · Received June 15, 2016

    Report

    Report Number
    3008087395-2016-00001
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 15, 2016
    Manufacturer
    SANARUS TECHNOLOGIES INC.
    Product Code
    GEH
    PMA / PMN Number
    K062896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VACUUM ASSISTED BIOPSY WAS PERFORMED PRIOR TO CRYOABLATION. THERE WAS VERY LITTLE MASS LEFT AFTER BIOPSY. PHYSICIAN REPORTED THAT THE PATIENT WAS GOING TO GET A MASTECTOMY IN THE FOLLOWING WEEKS. THE LESION WAS APPROXIMATELY 1CM FROM SKIN AND IT WAS RECOMMENDED BY SANARUS SALES REPRESENTATIVE TO HAVE SALINE SYRINGES AVAILABLE TO BUFFER THE SKIN IF NEED BE. TREATMENT ALGORITHM WAS 6-10-6 AND THE PROCEDURE WAS STOPPED AT 5:55 DURING THE FIRST FREEZE. THE ICE BALL BEGAN ENCROACHING ON THE SKIN AND BY THE TIME THE SALINE WAS MAKE AVAILABLE FOR THE PHYSICIAN THE SKIN BEGAN TO BLANCH AND IT WAS RECOMMENDED THAT THE PHYSICIAN STOP THE PROCEDURE AND IT WAS TERMINATED. A WARM BLANKET WAS APPLIED TO THE AFFECTED AREA OF THE SKIN AND BLANCHING QUICKLY BEGAN SUBSIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381922 VISICA 2 ICE PROBE CRYOABLATION PROBE GEH SANARUS TECHNOLOGIES INC. VP0600 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention