UNKNOWN URETERAL STENTS
Received May 23, 2026 · Event occurred May 15, 2026
Report 1018233-2026-03412 · MDR key 25266241
Device
Generic name
Ureteral Stents
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
UNK
Lot number
UNK
Product problems
- Accessory Incompatible
- Difficult to Insert
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 INLAY AND INLAY OPTIMA STENTS ARE REPORTED TO BE DIFFICULT TO ADVANCE OVER THE SOLO FLEX GUIDEWIRE. THEY REQUIRE ADDITIONAL FORCE OR GAUZE TO TRY TO ADVANCE. IT WAS DIFFICULT TO USE AND NOT TIMELY.