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	12/27/2025
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 transurethral left ureteroscopic holmium laser lithotripsy and stone removal plus ureteral stent placement in the department of surgery at our hospital.During the procedure, a ureteral stent was placed: inlay ureteral stents 4.7fr x 26 cm, code 1500000000010610.On (b)(6) 2025, the patient underwent transurethral ureteral stent removal in the outpatient operating room.Preoperative review of the urinary system x-ray showed no abnormalities.The patient was positioned for stone removal, cystoscopy showed normal bladder, and after routine disinfection and draping, the urethra was entered and the bladder examined.The left ureteral orifice was observed to contain the ureteral stent, the surface of which was covered with stones.Using foreign body forceps, the lower end of the ureteral stent was pulled toward the urethral opening, encountering significant resistance.It was considered that the upper segment of the ureteral stent was encrusted with stones.Cystoscopy was reintroduced to the bladder, and with foreign body forceps, the ureteral stent was slowly pulled from the ureteral orifice until it was completely removed through the urethra.The ureteral stent was found to be intact, but both ends were encrusted with stones.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent transurethral left ureteroscopic holmium laser lithotripsy and stone removal plus ureteral stent placement in the department of surgery at our hospital.During the procedure, a ureteral stent was placed: inlay ureteral stents 4.7fr x 26cm, code 1500000000010610.On (b)(6) 2025, the patient underwent transurethral ureteral stent removal in the outpatient operating room.Preoperative review of the urinary system x-ray showed no abnormalities.The patient was positioned for stone removal, cystoscopy showed normal bladder, and after routine disinfection and draping, the urethra was entered and the bladder examined.The left ureteral orifice was observed to contain the ureteral stent, the surface of which was covered with stones.Using foreign body forceps, the lower end of the ureteral stent was pulled toward the urethral opening, encountering significant resistance.It was considered that the upper segment of the ureteral stent was encrusted with stones.Cystoscopy was reintroduced to the bladder, and with foreign body forceps, the ureteral stent was slowly pulled from the ureteral orifice until it was completely removed through the urethra.The ureteral stent was found to be intact, but both ends were encrusted with stones.
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: 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/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/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 - b, d, 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® 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: 24171810
• Report Number: 1018233-2026-00260
• Device Sequence Number: 18646178
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: NGKP0843
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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: Other
• Patient Sex: Unknown