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

Catalog Number	788426
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient required a ureteral stent after ureteroscopic lithotripsy to eliminate obstructions caused by various benign, malignant, and post-traumatic conditions in the ureter.The patient used ureteral stent.Two weeks after the surgery, fluoroscopy revealed that the ureteral stent was placed in the upper left ureter.During the procedure, when the doctor was preparing to remove the stent, it broke off after being pulled out of the body.There was no resistance when removing the stent, indicating that it had broken off inside the patient.The tail end of the stent was broken off and removed using surgical forceps.The subsequent surgery was successful.Medical intervention was reported.
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.
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 bard inlay stent.Visual inspection of the one photo sample noted that one end of the stent pigtail was broken off.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: b, d, e, f, 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 patient required a ureteral stent after ureteroscopic lithotripsy to eliminate obstructions caused by various benign, malignant, and post traumatic conditions in the ureter.The patient used ureteral stent.Two weeks after the surgery, fluoroscopy revealed that the ureteral stent was placed in the upper left ureter.During the procedure, when the doctor was preparing to remove the stent, it broke off after being pulled out of the body.There was no resistance when removing the stent, indicating that it had broken off inside the patient.The tail end of the stent was broken off and removed using surgical forceps.The subsequent surgery was successful.Medical intervention was reported.

• 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: xernan lacson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23658271
• Report Number: 1018233-2025-10607
• Device Sequence Number: 9896969
• Product Code: FAD
• UDI-Device Identifier: 00801741015687
• UDI-Public: (01)00801741015687(11)250108(17)290826(10)NGJY2815
• 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): 03/20/2026

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: NGJY2815
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown