SONABLATE

Description of Event or Problem

ON (B)(6) 2020, PHYSICIAN NOTIFIED MANUFACTURER OF A PATIENT WHO HAD DEVELOPED A FISTULA SIX MONTHS POST ABLATION. THIS PATIENT HAD PREVIOUSLY HAD EXTERNAL BEAM RADIATION THERAPY (EBRT) TO THE PROSTATE AND ABLATION WAS BEING UTILIZED AS A SALVAGE MODALITY. THE PATIENT RECEIVED ABLATION BY PHYSICIAN ON (B)(6) 2019. PER THE PHYSICIAN, "MANAGED HIM WITH URETHRAL CATHETERIZATION AND ANTIBIOTICS FOR 6 WEEKS FIRST. THEN A COLOSTOMY HAS BEEN DONE. SINCE THE PATIENT IS OLD AND SARCOLEPTIC I WAS AWAY FROM PERINEAL REPAIR AND GRACILIS FLAP. THEREFORE I TRIED CYANOACRYLATE, TISSEL AND PRIMARY SUTURE. ALL FAILED OF COURSE. HE HAS STILL FISTULA AND COLOSTOMY. WE ARE DISCUSSING WITH HIM THE PULL THROUGH OPERATION NOWADAYS BUT HE LOOKS ADAPTED TO CURRENT SITUATION." AFTER REVIEW OF TRAINING RECORDS, IT APPEARS THAT PHYSICIAN DID NOT COMPLETE THE PHYSICIAN TRAINING PROGRAM.

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION OF THIS EVENT CLASSIFIED THE RECTAL FUSTULA AS A GRADE 3 (INVASIVE INTERVENTION INDICATED) EVENT BASED ON THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 5.0, WHICH MEANS INVASIVE INTERVENTION INDICATED. 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 PATIENT'S PREVIOUS MEDICAL HISTORY OF PROSTATIC EXTERNAL BEAM RADIATION THERAPY (EBRT) WOULD HAVE CONTRIBUTED TO THIS FISTULA. THE PREVIOUS MEDICAL HISTORY OF PROSTATIC EBRT HAS LIKELY ALSO CONTRIBUTED TO THE INABILITY OF THE FISTULA TO HEAL USING STANDARD TREATMENTS. THE INVESTIGATION OF THIS EVENT REVEALED THAT THE PHYSICIAN DID NOT COMPLETE THE PHYSICIAN TRAINING PROGRAM. THIS PHYSICIAN HAD NOT COMPLETED THE PHYSICIAN TRAINING PROGRAM. DURING A REVIEW OF MULTIPLE CASES COMPLETED BY THIS PHYSICIAN, IT WAS OBSERVED THAT HE WAS NOT USING THE DEVICE AS PER THE MANUFACTURER'S RECOMMENDATIONS OR STANDARDS. REMEDIAL TRAINING IS CURRENTLY BE 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: PATIENT'S PREVIOUS HISTORY OF PROSTATIC EBRT; PHYSICIAN UTILIZING HIGHER THAN RECOMMENDED POWER SETTINGS; PHYSICIAN NOT PAUSING TO ALLOW NEAR FIELD HEATING, AS WELL AS, RECTAL WALL AND PERIPROSTATIC FAT HEATING TO DISSIPATE; PHYSICIAN NOT UNDERGOING PHYSICIAN TRAINING.