SONABLATE

Description of Event or Problem

ON 26 AUG 2021, DOCTOR MADE MANUFACTURER AWARE OF A PREVIOUSLY TREATED ABLATION PATIENT WHO HAD DEVELOPED A RECTAL FISTULA. THIS PATIENT WAS TREATED ON (B)(6) 2021. UPON FURTHER INVESTIGATION THIS PATIENT HAD PREVIOUSLY UNDERGONE PROSTATE RADIATION AND LASER ABLATION. IT WAS ALSO NOTED DURING THE TREATMENT THAT THE PATIENT HAD CALCIFICATIONS THROUGHOUT THE PROSTATE. PER DOCTOR, THE PATIENT IS BEING SUCCESSFULLY MANAGED VIA URINARY DIVERSION WITH A URETHRAL CATHETER. UPON REVIEW OF THE CASE IMAGES, THERE WERE NO ALARMS, THE RECTAL WALL WAS NOT TARGETED, DUTY CYCLE AND POWER WERE WITHIN GUIDELINES. SALVAGE PROTOCOL WAS USED THROUGHOUT THE ABLATION.

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. FINALLY, THIS TREATMENT IS A MINIMALLY INVASIVE ULTRASOUND-BASED THERMAL ABLATION TECHNIQUE USED FOR 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 1-4 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 IMAGES WERE RETRIEVED AND REVIEWED FROM THE TREATMENT. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THE EQUIPMENT WORKED AS INTENDED. THERE ARE NO REPORTS OF MATERIAL ISSUES RELATED TO THIS PROCEDURE. THE PHYSICIAN IS A TRAINED PHYSICIAN WHO HAS COMPLETED THE TRAINING PROGRAM. THERE ARE NO REPORTS OF ENVIRONMENTAL ISSUES OR MEASUREMENT ISSUES RELATED TO THIS PROCEDURE. STANDARD OF CARE TREATMENT POST ABLATION INCLUDES THE USE OF A URINARY CATHETER. THE PHYSICIAN WAS ABLE TO MANAGE THIS EVENT WITH STANDARD OF CARE TREATMENT POST ABLATION USING A URINARY CATHETER.