SONABLATE

Description of Event or Problem

ON 03MAY2023, PHYSICIAN INFORMED MANUFACTURER OF A RECENT POSSIBLE FISTULA IN A PATIENT TREATED ON (B)(6) 2023. THE PATIENT HAD PREVIOUSLY FAILED RADIATION AND FAILED HIFU ABLATION, AND THIS WAS A SECOND HIFU ABLATION TREATMENT. PER PHYSICIAN, THIS PATIENT IS BEING MANAGED WITHOUT DIFFICULTY WITH A CATHETER, AND THE PHYSICIAN THINKS THIS WILL BE ABLE TO CLOSE WITHOUT SURGICAL INTERVENTION. ON (B)(6) 2023, PHYSICIAN INFORMED MANUFACTURER THAT PATIENT HAD A COLOSTOMY.

Additional Manufacturer Narrative

THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE PHYSICIAN ON THE PATIENT'S CONDITION. THE PATIENT HAD TO HAVE A COLOSTOMY. THIS EVENT WAS ORIGINALLY CLASSIFIED BY THE MANUFACTURER AS A GRADE 2 RECTAL FISTULA (SYMPTOMATIC, INVASIVE INTERVENTION NOT INDICATED). HOWEVER, BASED ON THE ADDITIONAL INFORMATION, THIS EVENT IS NOW CLASSIFIED AS A CTCAE GRADE 3 RECTAL FISTULA (INVASIVE INTERVENTION INDICATED) BASED ON THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 5.0.

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION OF THIS EVENT CLASSIFIED THE RECTAL "FISTULA" AS A GRADE 2 (SYMPTOMATIC, INVASIVE INTERVENTION NOT 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 HIFU 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. PATIENTS WHO HAVE HAD PREVIOUS RADIATION TREATMENT FOR PROSTATE DISEASE ARE AT HIGHER RISK FOR RECTAL FISTULA. FINALLY, THIS TREATMENT IS A MINIMALLY INVASIVE ULTRASOUND-BASED THERMAL ABLATION TECHNIQUE USED FOR HIFU ABLATION OF THE PROSTATE, INCLUDING THE PROSTATIC URETHRA, RESULTING IN COAGULATIVE NECROSIS OF THE PROSTATIC TISSUE. PATIENTS WHO RECEIVE ABLATION HAVE A SUPRAPUBIC CATHETER (SP TUBE) PLACED TO ASSIST IN EMPTYING THE BLADDER DURING THE HEALING PERIOD, WHICH IS USUALLY 2-4 WEEKS. IN SOME OCCASIONS, A PATIENT MAY HAVE A STANDARD FOLEY CATHETER INSTEAD OF AN SP TUBE. THE INVESTIGATION OF THIS EVENT SHOWED THAT CASE AND IMAGES WERE REVIEWED. PATIENT HAD A PREVIOUS MEDICAL HISTORY THAT INCLUDED RADIATION FOR PROSTATE CANCER AND PREVIOUS HIFU ABLATION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THE EQUIPMENT WORKED AS INTENDED. THERE WERE NO REPORTS OF MATERIAL ISSUES RELATED TO THIS PROCEDURE. THE PHYSICIAN HAS COMPLETED THE PHYSICIAN TRAINING PROGRAM AND HAS REGULARLY USED THE DEVICE SINCE 2013. THE CASE IMAGE REVIEW SHOWED EVIDENCE OF NEAR-FIELD HEATING IN THE PERIPROSTATIC FAT DUE TO PATIENT'S PREVIOUS TREATMENTS AND LITTLE USER INTERACTION WITH THE DEVICE TO ALLOW FOR COOLING OF NEAR FIELD HEAT. THERE ARE NO REPORTS OF ENVIRONMENTAL ISSUES OR MEASUREMENT ISSUES RELATED TO THIS PROCEDURE. STANDARD OF CARE TREATMENT POST HIFU ABLATION INCLUDES THE USE OF A URINARY CATHETER. THE PHYSICIAN HAS BEEN MANAGING THIS EVENT WITH STANDARD OF CARE TREATMENT POST ABLATION USING A URINARY CATHETER. ANY NEW INFORMATION ABOUT THE PATIENT CONDITION WILL BE PROVIDED IN FOLLOW-UP REPORTS, AS NEEDED. THE ROOT CAUSE OF THE RECTAL FISTULA CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE FOLLOWING FACTORS CONTRIBUTED TO THE RECTAL FISTULA: 1) PATIENT'S PAST MEDICAL HISTORY OF RADIATION FOR PROSTATE CANCER AND PREVIOUS ABLATION TO THE GLAND. 2) NEAR FIELD HEATING IN THE AREA OF THE PERIPROSTATIC FAT DUE PREVIOUS TREATMENTS AND LITTLE USER INTERACTION WITH THE DEVICE TO ALLOW FOR COOLING OF NEAR FIELD HEAT.

Description of Event or Problem

ON 03MAY2023, PHYSICIAN INFORMED MANUFACTURER OF A RECENT POSSIBLE FISTULA IN A PATIENT TREATED ON (B)(6) 2023. THE PATIENT HAD PREVIOUSLY FAILED RADIATION AND FAILED HIFU ABLATION, AND THIS WAS A SECOND HIFU ABLATION TREATMENT. PER PHYSICIAN, THIS PATIENT IS BEING MANAGED WITHOUT DIFFICULTY WITH A CATHETER, AND THE PHYSICIAN THINKS THIS WILL BE ABLE TO CLOSE WITHOUT SURGICAL INTERVENTION.