TULSA-PRO SYSTEM

Additional Manufacturer Narrative

THE MDR-FDA-3500A FORM WAS SUBMITTED TO FDA WITHIN THE REQUIRED 30 DAYS IN PAPER FORMAT THROUGH MAIL. WE WERE FOLLOWING A CONFLICTING FDA GUIDANCE THAT SPECIFY THAT MEDICAL DEVICES FDA-3500A FORM SHOULD BE SEND BY MAIL TO FDA. THE FDA REJECTED THE PAPER FORM AND RECOMENDED THAT WE SHOULD RE-SUBMIT THE FDA 3500A FORM ELECTRONICALLY THROUGH ESUBMITTER. SINCE THIS IS OUR FIRST ELECTRONIC REPORT, IT WAS DELAYED DUE TO SIGNUP PROCESS.

Description of Event or Problem

ON (B)(6) 2023, PATIENT UNDERWENT A PROSTATE ABLATION PROCEDURE WITH THE TULSA-PRO TRANSURETHRAL ULTRASOUND ABLATION SYSTEM. THE PROCEDURE INVOLVES INSERTION OF AN ENDORECTAT COOLING DEVICE (ECD) FOR PASSIVE COOLING OF THE RECTUM DURING THE ABLATION PROCEDURE. THE TREATING UROLOGIST REPORTED THAT DURING DEVICE INSERTION, INITIAL IMAGING REVEALED THAT THE ECD WAS NOT PROPERLY INSERTED AND AN ADJUSTMENT WAS REQUIRED TO INSERT THE DEVICE FURTHER INWARDS. THE UROLOGIST REPORTED THAT SHE FELT RESISTANCE DURING THE INSERTION BUT EVENTUALLY WAS CAPABLE TO PUSH THE DEVICE FURTHER INSIDE THE BODY. SUBSEQUENT MR IMAGES, SHOWED THE PROPER PLACEMENT OF THE ECD AND THE TEAM PROCEEDED WITH THE ULTRASOUND TREATMENT OF THE PROSTATE WITH NO UNUSUAL ISSUES RELATED TO RECTAL COOLING. THE FOLLOWING DAY ((B)(6) 2023), PATIENT REPORTED PAIN IN HIS STOMACH. FOLLOW-UP CT IMAGES REVEALED RECTAL PERFORATION BEYOND THE TREATMENT AREA WHERE THE ECD TIP ENDS. THE RADIOLOGIST SUSPECTS THAT THIS PERFORATION HAS HAPPENED DUE TO THE MECHANICAL DAMAGE DONE BY THE EXCESSIVE INSERTION OF THE ECD. RADIOLOGIST MENTIONED THAT THE PATIENT HAD PREVIOUS PROSTATE RADIATION THERAPY AND THEREFORE HIS RECTAL TISSUE COULD BE VULNERABLE AND UNSTABLE. THE PATIENT RECEIVED ADDITIONAL SURGICAL INTERVENTION OF PROTECTIVE STOMA AND VAC (VACUUM-ASSISTED CLOSURE) ON THE HOLE IN THE RECTAL WALL, WHICH RESULTED IN PROLONGED HOSPITALIZATION.