BARD® INLAY OPTIMA® URETERAL STENT

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO 'INTERMITTENT PAIN AND DISCOMFORT IN THE LEFT LUMBAR AND BACK REGION FOR 5 DAYS. AFTER EXCLUDING SURGICAL CONTRAINDICATIONS AND SIGNING THE SURGICAL CONSENT FORM, ON (B)(6) 2026, UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT TRANSURETHRAL URETEROSCOPIC BILATERAL RENAL AND URETERAL STONE HOLMIUM LASER LITHOTRIPSY PLUS TRANSURETHRAL BILATERAL URETERAL STENT PLACEMENT. POSTOPERATIVE REVIEW ON (B)(6) 2026 INCLUDED AN ABDOMINAL UPRIGHT DR (KUB), SHOWING CHANGES AFTER BILATERAL URINARY D J STENT PLACEMENT. ON (B)(6) 2026 AT 12:41, THE INDWELLING CATHETER WAS REMOVED. AT 21:30 THAT EVENING, THE PATIENT EXPERIENCED INVOLUNTARY URINE LEAKAGE. PHYSICAL EXAMINATION REVEALED THE TIP OF THE PROTRUDING STENT VISIBLE AT THE URETHRAL MEATUS, WITH URINE LEAKAGE. URETERAL STENT DISPLACEMENT WAS CONSIDERED; AFTER DISINFECTION, THE TIP OF THE STENT WAS REINSERTED INTO THE BLADDER, AND THE URINARY LEAKAGE RESOLVED. ON (B)(6) 2026, A FOLLOW UP KUB SHOWED THE HEAD END OF THE LEFT URETERAL STENT HAD SIGNIFICANTLY MIGRATED DOWNWARD, SUGGESTING THE LEFT URETERAL STENT DISPLACEMENT CAUSED THE URINE LEAKAGE. THE PATIENT WAS BETTER ON (B)(6) AT 08:00 CHECKUP.

Additional Manufacturer Narrative

THE INITIAL REPORTER'S FACILITY NAME: AFFILIATED (B)(6) HOSPITAL. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.