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	12/30/2025
Type of Reportable Event	Serious Injury
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 and required removal of the stent.Stent 778426 had been in place for 10 days.During the procedure to remove the ureteral stent, it was discovered that the stent had encrustations (see photos), preventing its smooth removal.After clinical assessment, surgical intervention was chosen to remove the stent.The surgery was successfully completed, and the stent was successfully removed.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent ureteroscopic lithotripsy and stone removal for kidney stones and required removal of the stent.Stent 778426 had been in place for 10 days.During the procedure to remove the ureteral stent, it was discovered that the stent had encrustations (see photos), preventing its smooth removal.After clinical assessment, surgical intervention was chosen to remove the stent.The surgery was successfully completed, and the stent was successfully removed.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Photo sample evaluation: visual evaluation of the single returned photo sample confirmed the presence of encrustations on the stent.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: precautions: 5.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 or 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.Based on the investigation results, and no additional action is required at this time.Corrections: d, 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.

• 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: 24172255
• Report Number: 1018233-2026-00267
• Device Sequence Number: 21376859
• 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): 05/12/2026

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: NGKR3449
• 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: 05/12/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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
• Patient Sex: Unknown