BARD® INLAY® URETERAL STENT WITH NICORE¿ GUIDEWIRE

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER NAME: (B)(6). 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN OPENED THE STERILE PACKAGING, REMOVED THE STENT AND GUIDEWIRE, LUBRICATED THEM WITH STERILE WATER, AND ASSEMBLED THE STENT AND GUIDEWIRE IN PREPARATION FOR CATHETERIZATION. DURING THE PROCEDURE, IT WAS DISCOVERED THAT ONCE PART OF THE STENT HAD ENTERED THE PATIENT¿S BODY, IT COULD NO LONGER BE ADVANCED, RESULTING IN A FAILED CATHETERIZATION.