SONABLATE

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION OF THIS EVENT CLASSIFIED THE RECTAL FUSTULA 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 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. THE INVESTIGATION OF THIS EVENT SHOWED THAT CASE IMAGES WERE REVIEWED FROM THE TREATMENT. PHYSICIAN DID NOT REPORT THAT THE PATIENT HAS HAD TO UNDERGO ANY SURGICAL PROCEDURES TO CORRECT THE FISTULA. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THE EQUIPMENT WORKED AS INTENDED. THE PATIENT'S PREVIOUS MEDICAL HISTORY OF ABLATION WOULD HAVE CONTRIBUTED TO THIS FISTULA. THERE WERE NO REPORTS OF MATERIAL ISSUES RELATED TO THIS PROCEDURE. PHYSICIANS IN THE UNITED KINGDOM ARE NOT ALLOWED TO TREAT USING THE DEVICE WITHOUT UNDERGOING THE TRAINING PROGRAM WHICH INCLUDES DIDACTIC EDUCATION, OBSERVING LIVE CASES WITH AN EXPERIENCED USER, PERFORMING LIVE CASES WITH AN EXPERIENCED USER, AND A FINAL SIGN OFF OF APPROVAL TO USE THE DEVICE BY AN EXPERIENCED USER. THERE ARE NO REPORTS OF ENVIRONMENTAL ISSUES TO THIS PROCEDURE. THERE ARE NO REPORTS OF MEASUREMENT 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: PATIENT'S PREVIOUS HISTORY OF ABLATION; AND PATIENT HAVING SIGNIFICANT PROSTATIC CALCIFICATIONS.

Description of Event or Problem

ON (B)(6) 2021, THE PHYSICIAN REQUESTED TO REVIEW CASE IMAGES FROM A PREVIOUS CASE WHERE A PATIENT DEVELOPED A RECTAL FISTULA POST PROCEDURE. AFTER A REVIEW OF THE CASE IMAGES, THE PHYSICIAN REPORTED: "IT WAS A REDO (2ND ABLATION) BY A COLLEAGUE. LOOKS LIKE IT WAS QUITE A DIFFICULT TREATMENT, AS WAS DOCUMENTED AT THE TIME, AND VIEWS WERE POOR, PARTLY DUE TO CALCIFICATION. IN HINDSIGHT, IT WOULD HAVE BEEN BETTER TO HAVE NOT PROCEEDED GIVEN THE VIEWS AVAILABLE. THERE WAS ALSO SOME RECTAL TETHERING FROM PREVIOUSLY." PHYSICIAN DID NOT REPORT ANY SURGICAL INTERVENTIONS FOR THE PATIENT.