BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOABLATION DEVICE, ARGON GAS

    MDR report key: 726078 · Received May 30, 2006

    Report

    Report Number
    MW1039407
    Event Type
    Death
    Date Received
    May 30, 2006
    Date of Event
    January 4, 2006
    Report Date
    May 30, 2006
    Manufacturer
    *
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING CRYOABLATION OF A SMALL RECURRENT RENAL CELL CARCINOMA WHEN HE WAS NOTED TO STOP BREATHING, APPROXIMATELY 10 MINUTES INTO THE CRYOABLATION, AND WAS NOT ABLE TO BE RESUSCITATED. REVIEW OF ANESTHESIA REVEALS THE DOSAGES WOULD NOT HAVE CAUSED THE RESPIRATORY PROBLEM. ACCORDING TO THE SURGEON THE MEDICAL DEVICE WAS WORKING APPROPRIATELY, ALTHOUGH IT WAS NOT ABLE TO BE EXAMINED. AN AUTOPSY REVEALED NO CHANGES SUGGESTIVE OF ANAPHYLAXIS. THE DEATH CERIFICATE HAS THE CAUSE OF DEATH AS "CARDIAC ARREST DURING CONSCIOUS SEDATION WITH VERSED AND FENTANYL FOR CRYOABLATION OF RECURRENT RENEAL CELL CARCINOMA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOABLATION DEVICE, ARGON GAS * GEH * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death