BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEEDNET CRYOTHERAPY SYSTEM

    MDR report key: 1866398 · Received September 10, 2010

    Report

    Report Number
    9616793-2010-00015
    Event Type
    Death
    Date Received
    September 10, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 27, 2010
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED THAT NO DEVICE FAILURE OCCURRED. PT DEATH FROM BLEEDING FOLLOWING CRYOTHERAPY PROCEDURES ARE A VERY RARE OCCURRENCE. BLEEDING, IN GENERAL, IS A RARE BUT KNOWN POTENTIAL ADVERSE EVENT WHEN TREATING THE LIVER WITH CRYOTHERAPY AS DOCUMENTED IN THE FOLLOWING LITERATURE REFERENCES: ADAM, RENE ET AL., ARCH SURG. 2002; 137: 1332-1339. HINSHAW, J LOUIS AND LEE, FRED T, TECH VASC INTERVENTIONAL RAD 2007; 10:47-57. MALA, TOM, MINIMALLY INVASIVE THERAPY AND ALLIED TECHNOLOGIES, 2006; 15:1, 9-17. SIEFERT, JK ET AL, J.R. COLL. SURG. EDINB., 43, JUNE 1998, 141-154. THE ARTICLES BY SIEFERT AND MALA REPORT A DEATH RATE OF APPROXIMATELY 1.6%. ALTHOUGH BLEEDING IS RARE, THE ARTICLE BY HINSHAW REPORTED THAT POSTPROCEDURE HEMORRHAGE IS THE MOST FREQUENT COMPLICATION OF HEPATIC CRYOABLATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEDNET CRYOTHERAPY SYSTEM CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRCH2024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death