BARD® INLAY OPTIMA® URETERAL STENT

Description of Event or Problem

IT WAS REPORTED THAT DR. FROM (B)(6) HOSPITAL AFFILIATED WITH (B)(6), WHILE PERFORMING A URETEROSCOPIC LITHOTRIPSY AND STONE REMOVAL FOR A PATIENT, DISCOVERED A CREASE IN THE URETERAL STENT DURING PREPARATION FOR PLACEMENT, WITH A NOTICEABLE BEND AND COLLAPSE, AND THEREFORE REPLACED IT WITH ANOTHER URETERAL STENT.

Additional Manufacturer Narrative

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: SECTION 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.