SONABLATE

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION OF THIS EVENT IS NOT YET COMPLETED. THE MANUFACTURER HAS ASKED THE PHYSICIAN FOR DETAILS AND IMAGES FOR THE CASE, AS WELL AS PERTINENT PATIENT INFORMATION/HISTORY. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER HAS CLASSIFIED THE RECTAL FISTULA AS A GRADE 3 (INVASIVE INTERVENTION INDICATED) EVENT BASED ON THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 5.0. THE CTCAE IS PUBLISHED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES AND USED FOR ADVERSE EVENT REPORTING PURPOSES. A GRADING (SEVERITY) LEVEL IS GIVEN TO EACH ADVERSE EVENT TERM. RECTAL FISTULA IS DEFINED BY THE MANUFACTURER'S HARM IDENTIFICATION AND SEVERITY ANALYSIS DOCUMENTATION ACCORDING TO THE CTCAE: RECTAL WALL INJURY/RECTAL FISTULA - DURING ABLATION TREATMENT, THERE IS A RISK OF DAMAGE TO THE RECTAL WALL (RECTAL FISTULA) FROM THE HEAT GENERATED DURING THE TREATMENT. DAMAGE TO THE RECTAL WALL CAN LEAD TO BLEEDING, INFECTION AND INCONTINENCE AND MAY REQUIRE SURGICAL INTERVENTION TO CORRECT.

Description of Event or Problem

ON (B)(6) 2023, PHYSICIAN REPORTED TO MANUFACTURER THAT HE SAW A PREVIOUS PATIENT THE WEEK BEFORE WHO HAD A RECTAL WALL INJURY. THE PATIENT HAD BEEN TREATED ON (B)(6) 2022. PER THE INFORMATION ABLE TO BE GATHERED FROM THE PHYSICIAN, THIS IS A RADIATION SALVAGE PATIENT AND PSA NEVER DECREASED FROM THE RADIATION. PHYSICIAN FOUND THERE WAS LARGE CAVITATION IN PROSTATE AREA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. INFORMATION ON THE PATIENT'S PREVIOUS MEDICAL HISTORY AND THE CASE IMAGES WERE STILL BEING REQUESTED BY THE MANUFACTURER FOR REVIEW OF THE TREATMENT.

Description of Event or Problem

ON 20FEB2023, PHYSICIAN REPORTED TO MANUFACTURER THAT HE SAW A PREVIOUS PATIENT THE WEEK BEFORE WHO HAD A RECTAL WALL INJURY. THE PATIENT HAD BEEN TREATED ON (B)(6) 2022. PER THE INFORMATION ABLE TO BE GATHERED FROM THE PHYSICIAN, THIS IS A RADIATION SALVAGE PATIENT AND PSA NEVER DECREASED FROM THE RADIATION. PHYSICIAN FOUND THERE WAS LARGE CAVITATION IN PROSTATE AREA.

Additional Manufacturer Narrative

THE MANUFACTURER RECEIVED ADDITIONAL DETAILS AND IMAGES FOR THE CASE, AS WELL AS PERTINENT PATIENT INFORMATION/HISTORY. THE MANUFACTURER'S INVESTIGATION OF THIS EVENT CLASSIFIED THE RECTAL FISTULA AS A GRADE 3 (INVASIVE INTERVENTION INDICATED) EVENT BASED ON THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 5.0. THE CTCAE IS PUBLISHED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES AND USED FOR ADVERSE EVENT REPORTING PURPOSES. A GRADING (SEVERITY) LEVEL IS GIVEN TO EACH ADVERSE EVENT TERM. RECTAL FISTULA IS DEFINED BY THE MANUFACTURER'S HARM IDENTIFICATION AND SEVERITY ANALYSIS DOCUMENTATION ACCORDING TO THE CTCAE: RECTAL WALL INJURY/RECTAL FISTULA - DURING ABLATION TREATMENT, THERE IS A RISK OF DAMAGE TO THE RECTAL WALL (RECTAL FISTULA) FROM THE HEAT GENERATED DURING THE TREATMENT. DAMAGE TO THE RECTAL WALL CAN LEAD TO BLEEDING, INFECTION AND INCONTINENCE AND MAY REQUIRE SURGICAL INTERVENTION TO CORRECT. THIS RISK CAN BE MINIMIZED BY CONSTANT MONITORING OF THE TEMPERATURE IN THE PROBE TIP AND BY THE USE OF A COOLING DEVICE TO CONTROL THE TEMPERATURE OF THE PROBE TIP. HOWEVER, THIS HAZARD CANNOT BE AVOIDED COMPLETELY. THERE WERE NO REPORTS OF EQUIPMENT RELATED ISSUES FOR THE CONSOLE. THE EQUIPMENT WORKED AS INTENDED. THERE ARE NO REPORTS OF ENVIRONMENTAL ISSUES TO THIS PROCEDURE. THERE ARE NO REPORTS OF MEASUREMENT ISSUES RELATED TO THIS PROCEDURE. THERE WERE NO REPORTS OF MATERIAL ISSUES RELATED TO THIS PROCEDURE. THE PHYSICIAN HAS COMPLETED THE REQUIRED TRAINING AND HAS COMPLETED OVER 50 CASES; HOWEVER, THE PHYSICIAN WAS NOT USING THE DEVICE AS PER THE MANUFACTURER'S RECOMMENDATIONS OR STANDARDS. THE ROOT CAUSE OF THE RECTAL FISTULA CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE FOLLOWING FACTORS LIKELY CONTRIBUTED TO THE RECTAL FISTULA: THE PATIENT HAD UNDERGONE FAILED RADIATION THERAPY FOR PROSTATE CANCER IN THE PAST. SALVAGE PATIENTS HAVE A HIGHER RISK OF DEVELOPING A FISTULA POST ABLATION. UNCONTROLLED NEAR FIELD HEATING IN THE AREA OF THE PERIPROSTATIC FAT DUE TO A LACK OF INTERACTION WITH THE DEVICE TO ALLOW FOR COOLING.