URO-GUIDE 8.5 X 26 CM WO/ GW

Additional Manufacturer Narrative

THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER A DIFFICULT URETHRAL STENT PLACEMENT ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL PRESENTING WITH UROSEPSIS ON (B)(6) 2024. AN ABDOMINAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND IT WAS DISCOVERED THAT THE STENT HAD MIGRATED (FROM RENAL PELVIS INTO THE BLADDER) AND THEREFORE HAD TO BE REMOVED AND A SIMILAR DEVICE PLACED. THE DOCTOR REPORTS NO ABNORMALITIES WITH RESPECT TO THE STANDARD DESIGN OF THE DEVICE (PRODUCT APPARENTLY NOT COMPROMISED) HOWEVER, THE DOCTOR COMPLAINS OF DIFFICULTIES IN THE PLACEMENT OF THE STENT AND UNABLE TO CREATE AN ADEQUATE SEAL CURL IN THE UPPER URINARY TRACT, THUS LED TO MIGRATING OF THE DEVICE. THERE WERE NO DELAYS REPORTED DURING PROCEDURE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.