BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCRYO

    MDR report key: 479440 · Received August 21, 2003

    Report

    Report Number
    2030653-2003-00002
    Event Type
    Injury
    Date Received
    August 21, 2003
    Date of Event
    July 25, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: PERCUTANEOUS CRYOABLATION OF LUNG TUMOR. DURING THE INSERTION OF THE PROBE AND BEFORE THERAPY WAS DELIVERED, THE PHYSICIAN NOTED BLOOD POOLING IN LUNG. AT THAT TIME, TREATMENT WAS DISCONTINUED. THE BLEEDING WAS ATTRIBUTED TO THE PUNCTURE OF A VESSEL DURING THE PROBE INSERTION PROCEDURE.

    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 Hospitalization