SONABLATE

Description of Event or Problem

ON 04MAR2024, THE MANUFACTURER WAS MADE AWARE BY THE PHYSICIAN OF A PATIENT THAT HAD DEVELOPED A FISTULA WHICH MAY HAVE STEMMED FROM A HIFU TREATMENT PERFORMED ON (B)(6) 2023. IT WAS INDICATED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A FAILED RADIATION TREATMENT OF THE PROSTATE.

Additional Manufacturer Narrative

DURING HIFU 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 FOLLOWING FACTORS LIKELY CONTRIBUTED TO THE RECTAL FISTULA: 1. THE PATIENT HAD UNDERGONE FAILED RADIATION THERAPY FOR PROSTATE CANCER IN THE PAST. SALVAGE PATIENTS HAVE A HIGHER RISK OF DEVELOPING A FISTULA POST HIFU. 2. A THICK RECTAL WALL AND UNCONTROLLED NEAR FIELD HEATING IN THE AREA OF THE PERIPROSTATIC FAT DUE TO A LACK OF INTERACTION WITH THE DEVICE TO ALLOW FOR COOLING. 3. THE PHYSICIAN INDICATED THE PATIENT HAS A HISTORY OF DIFFICULTY BOWEL MOVEMENTS FOR YEARS.