PERCUFLEX

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER FACILITY NAME. (B)(6) HOSPITAL. BLOCK E1: INITIAL REPORTER FACILITY ADDRESS 1 AND CITY. (B)(6). BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT.

Description of Event or Problem

IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A URETERAL STENT INSERTION IN THE KIDNEY. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE GUIDEWIRE WAS REMOVED UPON PLACING THE STENT, IT WAS NOTICED THAT THE STENT WAS WRINKLED AND WAS CLUMPED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.