PERCUFLEX

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. PATIENT CODE E2328 CAPTURES THE REPORTABLE EVENT OF RESIDUAL STONES IN THE URETER. IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY.

Description of Event or Problem

IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT DURING A URETEROSCOPIC LITHOTRIPSY AND STONE EXTRACTION PROCEDURE ON (B)(6) 2026. ON (B)(6) 2026, AN ABDOMINAL COMPUTED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED AND REVEALED THAT THE STENT HAD THICKENED AND IRREGULARITY AT THE DISTAL END OF THE URINARY STENT WITHIN THE BLADDER WAS OBSERVED. ON (B)(6) 2026, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE. DURING THIS PROCEDURE, STONE ATTACHMENT TO THE URETERAL STENT WAS OBSERVED, AND RESIDUAL STONES IN THE URETER AND RENAL PELVIS WERE ALSO IDENTIFIED. THE STENT WAS SUCCESSFULLY REMOVED AND THERE WAS NO INFORMATION IF A NEW STENT WAS PLACED. THE RESIDUAL STONES IN THE URETER AND RENAL PELVIS WERE EXTRACTED AND THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED.