MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT

Catalog Number	788426
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complete initial reporter facility name is (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.
Event or Problem Description
It was reported that the on (b)(6) 2025, the patient needed to undergo cystoscopic lithotripsy to remove the stent.The ureteral stent was placed during soft endoscopic lithotripsy.After 30 days, the stent was planned to be removed.It was found that the stent was full of stones see the stent photo, and it was difficult to remove.After clinical judgment, surgical intervention was selected.The operation was successfully completed, and the stent was successfully removed without other effects.
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6).The reported event was confirmed, cause unknown.Received 1 photo sample of the stent where build up is present on the outside of the stent.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: d, e, h.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.
Event or Problem Description
It was reported that the on (b)(6) 2025, the patient needed to undergo cystoscopic lithotripsy to remove the stent.The ureteral stent was placed during soft endoscopic lithotripsy.After 30 days, the stent was planned to be removed.It was found that the stent was full of stones see the stent photo, and it was difficult to remove.After clinical judgment, surgical intervention was selected.The operation was successfully completed, and the stent was successfully removed without other effects.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22480333
• Report Number: 1018233-2025-05769
• Device Sequence Number: 8669018
• Product Code: FAD
• UDI-Device Identifier: 00801741015687
• UDI-Public: (01)00801741015687(11)240703(17)290228(10)NGJS4414
• 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): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 788426
• Device Lot Number: NGJS4414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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