Description of Event or Problem · 1
ON (B)(6) 2020, NEOTRACT WAS NOTIFIED OF AN (B)(6) YEAR OLD PATIENT WITH A PAST MEDICAL HISTORY OF DIABETES, PNEUMONIA, BLADDER CANCER, HEART DISEASE, URINARY RETENTION REQUIRING CATHETER DEPENDENCE, RENAL FAILURE, AND SIGNIFICANT HISTORY OF RECURRENT UTIS, WHO UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE WITH THE UROLIFT SYSTEM ON (B)(6) 2020. IN (B)(6) 2020, THE PATIENT HAD BEEN ADMITTED FOR A UTI DURING WHICH HE EXPERIENCED ACUTE RENAL FAILURE WITH RESIDUAL RENAL COMPROMISE. HE REMAINED ON A CATHETER AND EXPERIENCED REPEAT UTIS, FOR WHICH HE RECEIVED INTERMITTENT ANTIBIOTIC TREATMENT UNTIL HIS PROCEDURE DATE. PRE-PROCEDURE ON (B)(6) 2020, THE PATIENT¿S URINE CULTURE WAS CLEAR. POST PROCEDURE, HE WAS DISCHARGED WITH A CATHETER FOR 2 DAYS. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN INFECTION. IT WAS LATER REPORTED TO NEOTRACT THAT THE PATIENT HAD EXPERIENCED SEPSIS, AND HAD BEEN IN AND OUT OF HOSPITALS/ REHAB FACILITIES SINCE THE PROCEDURE. APPROXIMATELY IN (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT EXPIRED. ALTHOUGH THE OFFICIAL CAUSE OF DEATH IS UNKNOWN, THE PHYSICIAN STATED THAT HE DOES NOT FEEL THE PROCEDURE OR DEVICE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH OCCURRED APPROXIMATELY 8 WEEKS AFTER THE PROCEDURE.