SONABLATE

Additional Manufacturer Narrative

THIS EVENT OCCURRED TWO DAYS POST HIFU TREATMENT. THE INVESTIGATION OF THIS EVENT SHOWED THAT THE CASE AND IMAGES ACQUIRED DURING THE PROCEDURE WERE REVIEWED BY THE MANUFACTURER'S CASE SUPPORT TEAM MANAGER. THROUGHOUT THE REVIEW, THERE WAS NO EVIDENCE OF THE DEVICE MALFUNCTIONING. HIFU WAS DELIVERED IN A CONTROLLED MANNER, AND ABLATION SITES WERE PLACED IN APPROPRIATE LOCATIONS WITHIN THE PROSTATE. THERE WAS NO EVIDENCE OF DAMAGE TO SURROUNDING CRITICAL STRUCTURES. THE TREATMENT WAS PERFORMED IN ACCORDANCE WITH THE STANDARDS SET BY THE PHYSICIAN TRAINING PROGRAM. THERE WERE NO REPORTS OF EQUIPMENT RELATED ISSUES. THE PHYSICIAN AND HIFU TECHNICIAN REPORTED THAT THE EQUIPMENT WORKED AS INTENDED AND THAT THEY EXPERIENCED NO ALARMS DURING THE CASE. THE PHYSICIAN DID NOT IGNORE ANY ALARMS OR MISUSE THE DEVICE. THERE WERE NO REPORTS OF MATERIAL ISSUES RELATED TO THIS PROCEDURE. THE PHYSICIAN IS A TRAINED HIFU PHYSICIAN WHO HAS COMPLETED THE PHYSICIAN TRAINING PROGRAM. THIS IS THE FIRST TIME THIS PHYSICIAN OR ANY PHYSICIAN HAS REPORTED A PATIENT DEATH FOLLOWING HIFU. THERE ARE NO REPORTS OF ENVIRONMENTAL ISSUES. THERE ARE NO REPORTS OF MEASUREMENT ISSUES RELATED TO THIS PROCEDURE. THE PATIENT HAD A PREVIOUS MEDICAL HISTORY THAT INCLUDED SICKLE CELL ANEMIA. PATIENT HAD RECEIVED MEDICAL AND CARDIAC CLEARANCE PRIOR TO UNDERGOING THE PROCEDURE. BASED ON THE REVIEW OF THE DEVICE, THE CASE AND IMAGES, THE MANUFACTURER DOES NOT BELIEVE THE DEVICE OR PROCEDURE COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PHYSICIAN SHARED, "I DID ALSO FIND THAT WHILE ORIGINALLY OFFERED CONSENT FOR AN AUTOPSY THE FAMILY ULTIMATELY RESCINDED SO IT WAS NOT PERFORMED. UNFORTUNATELY, NO ADDITIONAL INFORMATION WILL BE FORTHCOMING TO FURTHER SHED LIGHT ON WHAT POSSIBLY COULD HAVE HAPPENED." HOWEVER, THE PHYSICIAN AGREED WITH THE THE MANUFACTURER STATING, "I AGREE THAT THE PATIENT'S DEMISE COULD NOT POSSIBLY BE RELATED TO HIS PROSTATE PROCEDURE."

Description of Event or Problem

ON (B)(6) 2023, PHYSICIAN MADE MANUFACTURER AWARE OF A PATIENT DEATH THAT OCCURRED. THE PATIENT HAD BEEN TREATED ON (B)(6) 2023. PHYSICIAN SHARED, "POST PROCEDURE [PATIENT] COMPLAINED OF BACK AND NECK PAIN - HIS EVALUATION HERE WAS POSSIBLY SUGGESTIVE OF A SICKLE CELL DISEASE CRISIS FOR WHICH HE WAS TRANSFERRED TO THE MEDICAL SERVICE OF OUR HOSPITAL. DURING [THE PATIENT'S] DETERIORATION, HE UNDERWENT CT SCANS OF THE HEAD, CHEST TO RULE OUT A PE, AS WELL AS ABDOMEN AND PELVIS. ALL WERE UNREMARKABLE. TROPONINS AND EKG WERE [WITHIN NORMAL LIMITS]."