MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 INLAY OPTIMA URETERAL STENT W/O GUIDEWIRE

Catalog Number	788726
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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.
Event or Problem Description
It was reported that on (b)(6) 2025, the customer implanted ureteral stent 788726 into a patient.The patient returned to the hospital on (b)(6) 2025, for stent removal.The procedure proved difficult during extraction, and upon removal, the stent was found completely encrusted with stones.The customer believed that the stent became completely encrusted with stones within less than two months of placement contradicts the long term retention capability promised in their product documentation.Consequently, the customer suspects a product quality issue and had filed a complaint.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), used ureteral stent.Visual inspection of the one photo sample noted showed the ureteral stent with visible calcification.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab(s) d and h.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.
Event or Problem Description
It was reported that on (b)(6) 2025, the customer implanted ureteral stent 788726 into a patient.The patient returned to the hospital on (b)(6) 2025, for stent removal.The procedure proved difficult during extraction, and upon removal, the stent was found completely encrusted with stones.The customer believed that the stent became completely encrusted with stones within less than two months of placement contradicts the long term retention capability promised in their product documentation.Consequently, the customer suspects a product quality issue and had filed a complaint.

• Brand Name: INLAY OPTIMA URETERAL STENT W/O GUIDEWIRE
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23729564
• Report Number: 1018233-2025-10849
• Device Sequence Number: 10631441
• Product Code: FAD
• UDI-Device Identifier: 00801741015847
• UDI-Public: (01)00801741015847(11)241213(17)271222(10)NGJY1750
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 788726
• Device Lot Number: NGJY1750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown