SONABLATE
Received Sep 26, 2019 · Event occurred Jan 1, 2019
Report 2951226-2019-00001 · MDR key 9124115
Device
Generic name
High Intensity Focused Ultrasound Device
Manufacturer
Focus Surgery, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
0 DA
- Fistula
- Fistula
Narrative
Description of Event or Problem
DR. (B)(6) REPORTED THAT ONE OF HIS PREVIOUS HIFU PATIENTS HAD DEVELOPED A RECTAL FISTULA. PATIENT WAS STATUS POST EXTERNAL BEAM RADIATION THERAPY (EBRT) AND BRACHYTHERAPY. PATIENT HAD A SUPRAPUBIC CATHETER PLACED THE DAY OF THE CASE. AFTER THE SUPRAPUBIC CATHETER WAS DISCONTINUED, PER THE PHYSICIAN, THE PATIENT DEVELOPED DIARRHEA WHICH WAS LATER DIAGNOSED AS A RECTAL FISTULA. DR. (B)(6) PLACED URETHRAL CATHETER WHICH WAS IN PLACE FOR 3 WEEKS AS OF (B)(6) 2019. PER DR. (B)(6) AND VERIFIED VIA A REVIEW OF THE CASE IMAGES, THE PROSTATE AND SVS WERE ABLATED. MANUFACTURER REQUESTED ACCESS TO THE PATIENT'S TREATMENT IMAGES TO REVIEW THE CASE, WHICH DR. (B)(6) WELCOMED. A REVIEW OF THE CASE IMAGES BY MANUFACTURER OCCURRED ON AUGUST 30, 2019 AND RESULTED IN THE FOLLOWING OBSERVATIONS: THE PATIENT HAD A THICKER THAN NORMAL RECTAL WALL, LIKELY FROM PREVIOUS PROSTATE EBRT AND BRACHYTHERAPY. THE PHYSICIAN FOLLOWED POWER RECOMMENDATIONS. THE PHYSICIAN UTILIZED THE 3/6 DUTY CYCLE THROUGHOUT THE CASE. THE EQUIPMENT WORKED AS INTENDED. THE PHYSICIAN DID NOT IGNORE ANY ALARMS OR BLATANTLY MISUSE THE DEVICE.