BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD THE URETERAL STENT IN PLACE FOR LESS THAN TWO MONTHS, AND SEVERE STONE ENCRUSTATION WAS FOUND, SO THE STENT WAS REMOVED AND A NEW STENT WAS IMPLANTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. (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.