MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® InLay Optima® Ureteral Stent with NiCore¿ Guidewire

Catalog Number	786624
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had the ureteral stent in place for less than two months, and severe stone encrustation was found, so the stent was removed and a new stent was implanted.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.(b)(6).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 the patient had the ureteral stent in place for less than two months, and severe stone encrustation was found, so the stent was removed and a new stent was implanted.The user was exposed to hazardous substances, blood, or body fluids.
Additional Manufacturer Narrative
Evaluation determined the product does not meet specifications, and no new product nonconformance was identified.Visual inspection of the one (1) received photo sample was performed upon intake.Photo #1 depicts calcification present on the stent.The labeling is found to be adequate.Dhr review for corporate lot no.Ngjt1273 catalog number 786624 (bard inlay optima ureteral stent, hydrophobic coated, open end with suture loop 6fr x 24cm with nitinol guidewire) used in the manufacture of the reported product did not show any rejects, planned deviations, reworks or component quality issues.As per investigation results, the annex g code was found to be g01-biological and chemical.Corrections made to tab(s) d, f, h initial reporter name: the second hospital of zhejiang university, school of medicine 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.

• Brand Name: Bard® InLay Optima® Ureteral Stent with NiCore¿ 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 ; +1(770)784-6100
• MDR Report Key: 25521767
• Report Number: 1018233-2026-03852
• Device Sequence Number: 21484410
• Product Code: FAD
• UDI-Device Identifier: 10801741015110
• UDI-Public: (01)10801741015110(11)240816(17)290228(10)NGJT1273
• 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): 09/15/2026

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: 786624
• Device Lot Number: NGJT1273
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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