BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCRYO

    MDR report key: 479430 · Received August 21, 2003

    Report

    Report Number
    2030653-2003-00001
    Event Type
    Death
    Date Received
    August 21, 2003
    Date of Event
    July 30, 2003
    Report Date
    August 21, 2003
    Manufacturer
    ENDOCARE, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: PERCUTANEOUS CRYOABLATION OF LUNG TUMOR. PT HAD LUNG TUMOR MEASURING OVER 5CM. DURING THE PERCUTANEOUS TUMOR ABLATION PROCEDURE, PHYSICIAN PUNCTURED A BLOOD VESSEL CAUSING MINOR BLEEDING. PHYSICIAN CONTINUED CRYOSURGICAL ABLATION OF TUMOR AND THE NEXT DAY THE PT CODED. THE PT SUBSEQUENTLY DIED IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCRYO CRYOSURGICAL CRYOPROBE GEH ENDOCARE, INC. PERC-24-S 03-0246

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death