BEUDAMED
    FDA Adverse Event Death Summary report: N

    2.4MM V-PROBE CRYOPROBE

    MDR report key: 24026982 · Received January 9, 2026

    Report

    Report Number
    3008262715-2026-00001
    Event Type
    Death
    Date Received
    January 9, 2026
    Date of Event
    December 1, 2025
    Report Date
    February 5, 2026
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY DR. (B)(6) ON (B)(6) 2026 WHICH CORRECTS INFORMATION PROVIDED IN THE INITIAL REPORT. CORRECTED DATA: B5 - CORRECTED INFORMATION RECEIVED FROM PHYSICIAN; H6 - CORRECTED HEALTH EFFECT CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS BASED ON NEW INFORMATION RECEIVED FROM PHYSICIAN; H11- MANUFACTURER NARRATIVE INCLUDES CORRECTED INFORMATION. MANUFACTURER NARRATIVE: CRYOABLATION WAS PERFORMED ON A 5 CM RENAL MASS. THERE WAS NO DEVICE MALFUNCTION. THE 4 CRYOPROBES AND CONSOLE FUNCTIONED NORMALLY AND AS EXPECTED. SEVERAL DAYS AFTER THE PROCEDURE, THE PATIENT PASSED AWAY. THE PHYSICIAN DID NOT REPORT ANY MALFUNCTION OF THE DEVICE AND THE INFORMATION ABOUT THE COMPLICATION AND DEATH WAS COMMUNICATED TO VARIAN STAFF VERBALLY APPROXIMATELY ONE WEEK AFTER THE PATIENT¿S DEATH. FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2026 FROM THE DR. (B)(6), INDICATED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A RENAL ABLATION PROCEDURE IN (B)(6) 2025, WHICH HAD BEEN REPORTED AS SUCCESSFUL. ACCORDING TO THE CLINICIAN, COMPUTED TOMOGRAPHY (CT) IMAGING WAS CONDUCTED INTRA-PROCEDURALLY, AS WELL AS ON POSTOPERATIVE DAY 1 AND DAY 2. NO ANOMALIES, ADVERSE FINDINGS, OR PROCEDURAL COMPLICATIONS WERE IDENTIFIED DURING THESE IMAGING ASSESSMENTS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED IN STABLE CONDITION. THE MANUFACTURER WAS FURTHER INFORMED THAT THE PATIENT¿S DEATH OCCURRED FOLLOWING A SURGICAL INTERVENTION PERFORMED AT ANOTHER HOSPITAL AFTER AN UNSPECIFIED PROCEDURE NOT ASSOCIATED WITH THE SUBJECT DEVICE. AT THE TIME OF THIS REPORT, NO CLINICAL DETAILS, MEDICAL RECORDS, OR INFORMATION REGARDING THE INDICATION FOR THE SUBSEQUENT SURGERY HAVE BEEN MADE AVAILABLE. THEREFORE, NO CAUSAL RELATIONSHIP BETWEEN THE CRYOTHERAPY PROCEDURE, THE SUBJECT DEVICE, AND THE REPORTED DEATH CAN BE ESTABLISHED. THE LOT NUMBER AND UDI FOR THE DEVICE ARE UNKNOWN AT THE TIME OF THIS REPORT. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE UDI AND ADDITIONAL DEVICE IDENTIFICATION INFORMATION FROM THE REPORTING CUSTOMER; HOWEVER, THE CUSTOMER IS UNWILLING TO RELEASE ANY FURTHER DETAILS AT THIS TIME. NO UDI INFORMATION WAS AVAILABLE THROUGH INTERNAL RECORDS. THIS MDR IS BEING SUBMITTED WITH THE INFORMATION CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEATH RESULTED AS A COMPLICATION OF AN UNINTENDED INJURY TO ADJACENT BOWEL DURING CRYOABLATION PROCEDURE OF A 5 CM RENAL MASS. THERE WAS NO DEVICE MALFUNCTION. THE 4 CRYOPROBES AND CONSOLE FUNCTIONED NORMALLY AND AS EXPECTED. INJURY TO ADJACENT BOWEL WAS A RESULT OF INSUFFICIENT HYDRODISSECTION AND LACK OF ADEQUATE DISTANCE BETWEEN THE EDGE OF THE ABLATION ZONE AND THE BOWEL. PHYSICIAN STATED THAT HE DID NOT REPEAT THE CT SCAN AFTER HYDRODISSECTION WHICH MIGHT HAVE SHOWN LACK OF ADEQUATE DISTANCE TO BOWEL. THIS RESULTED IN BOWEL INJURY AND SUBSEQUENT DEATH SEVERAL DAYS AFTER THE PROCEDURE. ADJACENT ORGAN INJURY IS AN INHERENT RISK AND A RARE BUT KNOWN COMPLICATION OF ABLATION PROCEDURES. THE PHYSICIAN DID NOT REPORT ANY MALFUNCTION OF THE DEVICE AND THE INFORMATION ABOUT THE COMPLICATION AND DEATH WAS COMMUNICATED TO VARIAN STAFF VERBALLY APPROXIMATELY ONE WEEK AFTER THE PATIENT¿S DEATH. THE LOT NUMBER AND UDI FOR THE DEVICE ARE UNKNOWN AT THE TIME OF THIS REPORT. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE UDI AND ADDITIONAL DEVICE IDENTIFICATION INFORMATION FROM THE REPORTING CUSTOMER; HOWEVER, THE CUSTOMER IS UNWILLING TO RELEASE ANY FURTHER DETAILS AT THIS TIME. NO UDI INFORMATION WAS AVAILABLE THROUGH INTERNAL RECORDS. THIS MDR IS BEING SUBMITTED WITH THE INFORMATION CURRENTLY AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A CRYOTHERAPY PROCEDURE WHICH INCLUDED HYDRODISSECTION OF A 5 CM RENAL MASS WAS PERFORMED. FOUR V-PROBES WERE USED. THE LESION WAS VERY CLOSE TO THE BOWEL. SEVERAL DAYS AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 FROM DR. (B)(6) INDICATED THE PATIENT HAD PREVIOUSLY UNDERGONE A RENAL ABLATION PROCEDURE IN (B)(6) 2025, WHICH WAS REPORTED AS SUCCESSFUL. CT IMAGING WAS PERFORMED DURING THE PROCEDURE, AS WELL AS POST-PROCEDURE ON DAY 1 AND DAY 2. NO ANOMALIES OR COMPLICATIONS WERE IDENTIFIED DURING THESE ASSESSMENTS, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT¿S DEATH OCCURRED FOLLOWING A SURGICAL INTERVENTION AT ANOTHER HOSPITAL AFTER AN UNSPECIFIED PROCEDURE. AT THIS TIME, THE CIRCUMSTANCES, CLINICAL DETAILS, AND CAUSAL RELATIONSHIP¿IF ANY¿BETWEEN THE REPORTED DEATH AND THE CRYOTHERAPY PROCEDURE REMAIN UNKNOWN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Description of Event or Problem · 0

    AFTER A CRYOTHERAPY PROCEDURE, DUE TO AN ERROR WITH THE HYDRODISSECTION, THE PATIENT PASSED AWAY. FOUR V-PROBES WERE USED. THE LESION WAS VERY CLOSE TO THE RECTUM AND THE USER DID NOT REIMAGE AFTER HYDRODISSECTION TO SEE IF THERE WAS ADEQUATE SPACE CREATED. THE ICE BALL EXPANDED TO THE RECTUM AND ABLATED A PART OF IT. IT WAS REPORTED THAT SUBSEQUENT ISCHEMIA OF THE BOWEL LED TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81219 2.4MM V-PROBE CRYOPROBE 2.4MM V-PROBE CRYOPROBE GEH VARIAN MEDICAL SYSTEMS CVA2400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death