BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
Received Apr 8, 2026 · Event occurred Apr 1, 2026
Report 1018233-2026-02307 · MDR key 24820776
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
786626
Lot number
NGKS1280
Product problems
- Calcified
Patient
NA · Unknown
- Exposure to Body Fluids
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE URETERAL STENT HAD BEEN IN PLACE FOR OVER A MONTH, AND IT IS ALMOST COMPLETELY COVERED WITH STONES AND HOSPITALIZED TO REPLACE THE IMPLANTED STENT. THE PATIENT WAS ALSO EXPOSED TO BODILY FLUID.
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.
Description of Event or Problem
IT WAS REPORTED THAT THE URETERAL STENT HAD BEEN IN PLACE FOR OVER A MONTH, AND IT IS ALMOST COMPLETELY COVERED WITH STONES AND HOSPITALIZED TO REPLACE THE IMPLANTED STENT. THE PATIENT WAS ALSO EXPOSED TO BODILY FLUID.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTIONS: B, E, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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.