PERCUFLEX?

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF UNSEALED DEVICE PACKAGING.

Description of Event or Problem

IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS TO BE USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY AND STONE EXTRACTION WITH POSTOPERATIVE STENT PLACEMENT. DURING UNPACKING IT WAS FOUND THAT THE PACKAGING WAS OPENED AND FOUND TO BE DAMAGED. DUE TO THE COMPROMISED INTEGRITY OF THE PACKAGING, CONTAMINATION OF THE DEVICE WAS SUSPECTED. THE DEVICE WAS THEREFORE DEEMED UNSUITABLE FOR USE AND WAS NOT UTILIZED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.