SONABLATE

Description of Event or Problem

ON 27 AUG 2020, PHYSYICAN REPORTED TO MANUFACTURER THAT A PREVIOUS PATIENT OF HIS HAD A RECTAL FISTULA, BUT THE FISTULA HAD SINCE HEALED. PHYSICIAN STATED HE BELIEVED THE CAUSE WAS DUE TO THE PATIENT SELF-TREATING A HEMORRHOID WITH AN UNADVISED TREATMENT APPLICATOR TIP. PHYSICIAN STATED THE FISTULA HEALED IN 2 WEEKS. DURING FURTHER INVESTIGATION PHYSICIAN REPORTED: "THE PROCEDURE WAS (B)(6). THE PATIENT USED A HEMORRHOID CREAM APPLICATOR IN HIS RECTUM AND PUNCTURED THE RECTUM. HE HAD WHAT WAS LIKELY A URETHROVESICAL FISTULA WITH URINE COMING OUT HIS RECTUM FOR 2 DAYS. IT HEALED COMPLETELY WITH A FOLEY IN PLACE FOR 2 WKS."

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 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 THE CASE WAS REVIEWED. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THE EQUIPMENT WORKED AS INTENDED. PHYSICIAN DID NOT REPORT ANY PREVIOUSLY MEDICAL HISTORY THAT CONTRIBUTED TO THIS FISTULA; HOWEVER, PER THE PHYSICIAN, THE FISTULA PRESENTED AFTER THE PATIENT USED A HEMORRHOID CREAM APPLICATOR IN HIS RECTUM AND PUNCTURED THE RECTUM. THE PHYSICIAN FURTHER REPORTED THAT THE FISTULA FULLY HEALED WITHOUT ANY ADDITIONAL INTERVENTION. 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. THE ROOT CAUSE OF THE RECTAL FISTULA IS DETERMINED TO BE A RESULT OF PATIENT USE OF HEMORRHOID CREAM APPLICATOR 2 DAYS POST ABLATION.