BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
Received Apr 11, 2026 · Event occurred Mar 30, 2026
Report 1018233-2026-02420 · MDR key 24850171
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
786626
Lot number
UNK
Product problems
- Inadequacy of Device Shape and/or Size
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY A PHYSICIAN STATED THAT "NO HE/SHE WAS NOT ABLE TO SUCCESSFULLY RELIEVE THE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE" BECAUSE "MARKED OBSTRUCTION", REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM. ALSO STATED THAT "NO THE GUIDEWIRE DID NOT SUPPORT STENT PLACEMENT PROCEDURE" BECAUSE "OVERLY NARROW URETERS". REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM.
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 CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY A PHYSICIAN STATED THAT "NO HE/SHE WAS NOT ABLE TO SUCCESSFULLY RELIEVE THE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE" BECAUSE "MARKED OBSTRUCTION", REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM. ALSO STATED THAT "NO THE GUIDEWIRE DID NOT SUPPORT STENT PLACEMENT PROCEDURE" BECAUSE "OVERLY NARROW URETERS". REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. 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.