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

Catalog Number	788626
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter complete facility name: (b)(6) hospital of traditional (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: 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) 2026, the patient underwent a cystoscopy stent removal procedure to extract the stent.An ureteral stent had been placed during a flexible ureteroscopy lithotripsy procedure 180 days prior.During the planned removal, the stent was found to be extensively encrusted with calculi, making extraction difficult.Following clinical assessment, surgical intervention was selected.The procedure was completed successfully, with the stent removed without complications.Surgical intervention was selected to remove the stent.The procedure was completed successfully, the stent was removed without incident, and there were no other effects.
Event or Problem Description
It was reported that, on 09feb2026, the patient underwent a cystoscopy stent removal procedure to extract the stent.An ureteral stent had been placed during a flexible ureteroscopy lithotripsy procedure 180 days prior.During the planned removal, the stent was found to be extensively encrusted with calculi, making extraction difficult.Following clinical assessment, surgical intervention was selected.The procedure was completed successfully, with the stent removed without complications.Surgical intervention was selected to remove the stent.The procedure was completed successfully, the stent was removed without incident, and there were no other effects.
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.The reported event is addressed within the labeling as it states: precautions: ¿ do not use device if package is opened or damaged.¿ ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient-specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.Data on file at bd.Potential complications: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema.¿ extravasation.¿ fistula formation.¿ hemorrhage.¿ hydronephrosis.¿ infection.¿ stone formation.¿ ureteral reflux.¿ loss of renal function.¿ pain or discomfort.¿ peritonitis.¿ perforation of kidney, renal pelvis, ureter and/or bladder.¿ stent dislodgement, fragmentation, migration, occlusion.¿ stent encrustation.¿ ureteral erosion.¿ urinary symptoms.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,e,f,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.

• 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: 24394223
• Report Number: 1018233-2026-01035
• Device Sequence Number: 8580136
• Product Code: FAD
• 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): 05/27/2026

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: 788626
• Device Lot Number: NGJW2476
• Was Device Available for Evaluation?: No
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown