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

Catalog Number	778426
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on (b)(6) 2025, the patient underwent ureteroscopic lithotripsy and stone removal for kidney stones.A stent had been in place for 20 days and was scheduled for removal during surgery.During preparation to extract the ureteral stent, encrustation was observed on the stent, preventing its smooth removal.Following clinical assessment, surgical intervention was chosen to extract the stent.The procedure was completed successfully, and the stent was removed without incident.
Additional Manufacturer Narrative
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) 2025, the patient underwent ureteroscopic lithotripsy and stone removal for kidney stones.A stent had been in place for 20 days and was scheduled for removal during surgery.During preparation to extract the ureteral stent, encrustation was observed on the stent, preventing its smooth removal.Following clinical assessment, surgical intervention was chosen to extract the stent.The procedure was completed successfully, and the stent was removed without incident.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation: visual evaluation of the one returned photo samples of the stent confirmed the presence of stone formation.Therefore, reported event is confirmed.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "material selection".However, there was insufficient information to confirm this potential root cause.The reported event is addressed within the labeling as it states: 5.Ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and 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.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 investigation results, and no additional action is required at this time.Correction: d,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® 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24172899
• Report Number: 1018233-2026-00285
• Device Sequence Number: 18519353
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• 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): 06/05/2026

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: 778426
• Device Lot Number: NGJX2116
• Date Returned to Manufacturer: 01/07/2026
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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
• Patient Sex: Unknown