BARD® INLAY OPTIMA® URETERAL STENT
Received Apr 28, 2026 · Event occurred Apr 21, 2026
Report 1018233-2026-02711 · MDR key 25019157
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
788626
Lot number
MYKY0550
Product problems
- Deformation Due to Compressive Stress
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. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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 BEFORE USE, THE URETERAL STENTS PIGTAIL SECTION HAD A CREASE AND DID NOT STRETCH; IT WAS KINKED.