SONABLATE

Additional Manufacturer Narrative

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. THE INVESTIGATION OF THIS EVENT REVEALED THAT THE PHYSICIAN DID NOT COMPLETE THE PHYSICIAN TRAINING PROGRAM, AND IT WAS OBSERVED THAT HE WAS NOT USING THE DEVICE AS PER THE MANUFACTURER'S RECOMMENDATIONS OR STANDARDS. REMEDIAL TRAINING IS CURRENTLY BEING COMPLETED BY THIS PHYSICIAN. CASE IMAGES WERE REVIEWED FROM THE TREATMENT. 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 ROOT CAUSE OF THE RECTAL FISTULA CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE FOLLOWING FACTORS CONTRIBUTED TO THE RECTAL FISTULA: RECTAL WALL DISTANCE FROM TRANSDUCER IN THE FIRST ZONE WAS BELOW THE RECOMMENDED LIMIT AND IMPEDED TRANSDUCER MOTION ON SEVERAL OCCASIONS; UNCONTROLLED NEAR FIELD HEATING IN THE AREA OF PERIOPROSTATIC FAT DUE TO A LACK OF INTERACTION WITH THE DEVICE TO ALLOW FOR COOLING; AND INCOMPLETE PHYSICIAN TRAINING.

Description of Event or Problem

ON (B)(6) 2022, PHYSICIAN NOTIFIED MANUFACTURER OF A PATIENT HE HAD TREATED THAT HAD DEVELOPED A FISTULA. THIS PATIENT WAS TREATED ON (B)(6) 2021. WHILE REVIEWING THE PATIENT IMAGES WITH THE PHYSICIAN, IT WAS NOTED THAT ELEVATED RIM VALUES AND HYPERECHOIC CHANGES INDICATIVE OF UNCONTROLLED HEATING INFERIOR TO THE ZONE AND IN THE PERIPROSTATIC FAT WERE OBSERVED CONSISTENTLY THROUGHOUT THE CASE. NO ACTION TO ALLOW FOR THE HEAT TO DISSIPATE WAS NOTED IN THE IMAGES, IE PAUSING OR SWITCHING THE DUTY CYCLE. IN THE POSTERIOR ZONE, SEVERAL ABLATION SITES INCLUDED PERIPROSTATIC FAT WHICH SHOWED HYPERECHOIC CHANGES WHEN ABLATION WAS DELIVERED. PHYSICIAN ASKED ABOUT THE TEMPERATURE OF THE WATER INSIDE THE BALLOON, AND IF THAT COULD HAVE AN IMPACT. IT WAS NOTED THAT THE TEMPERATURE FELL WITHIN NORMAL RANGE DURING AN ABLATION PROCEDURE. PHYSICIAN WAS RECEPTIVE THAT UNCONTROLLED HEATING MAY HAVE CAUSED THE INJURY, AND ACTIONS SUCH AS SWITCHING TO A SLOWER DUTY CYCLE AND PAUSING SHOULD BE TAKEN WHEN NEAR FIELD HEATING IS OBSERVED. THIS PATIENT WAS REFERRED TO A RECTAL SURGEON TO REPAIR HIS RECTAL INJURY.