BARD® INLAY OPTIMA® URETERAL STENT
Received Apr 4, 2026 · Event occurred Mar 31, 2026
Report 1018233-2026-02240 · MDR key 24784430
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
788714
Lot number
UNK
Product problems
- Inadequacy of Device Shape and/or Size
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INITIAL REPORTER'S PHONE NUMBER: (B)(6). 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: 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.
Description of Event or Problem
IT WAS REPORTED BY CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY A PHYSICIAN STATED THAT "NO HE OR SHE WAS NOT ABLE TO SUCCESSFULLY RELIEVE THE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE" BECAUSE "EXTERNAL COMPRESSION" REFERENCING PRODUCT CODE 788714, INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 7 FR, 14CM.