MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY® VERSA FIT® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Catalog Number	777600
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent percutaneous nephroscopic laser lithotripsy of the right renal pelvis.A right ureteral stent (6f bard) was inserted post-operatively to dilate the ureteral stricture.The plan was to remove the right ureteral stent three months later.On (b)(6), the patient came to the hospital for stent removal.An abdominal kub x-ray revealed stone formation and encrustation on the surface of the stent, making removal difficult.On (b)(6), under general anesthesia, the patient underwent right percutaneous nephroscopic pneumatic ballistic lithotripsy and stent removal.The surgery was successful.
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.
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: "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." 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 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 on (b)(6) 2025, the patient underwent percutaneous nephroscopic laser lithotripsy of the right renal pelvis.A right ureteral stent (6f bard) was inserted post operatively to dilate the ureteral stricture.The plan was to remove the right ureteral stent three months later.On (b)(6) the patient came to the hospital for stent removal.An abdominal kub x ray revealed stone formation and encrustation on the surface of the stent, making removal difficult.On (b)(6) under general anesthesia, the patient underwent right percutaneous nephroscopic pneumatic ballistic lithotripsy and stent removal.The surgery was successful.

• Brand Name: BARD® INLAY® VERSA FIT® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: 24171723
• Report Number: 1018233-2026-00247
• Device Sequence Number: 13299304
• Product Code: FAD
• UDI-Device Identifier: 10801741014502
• UDI-Public: (01)10801741014502(11)250506(17)291231(10)NGKR0248
• 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): 05/12/2026

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: 777600
• Device Lot Number: NGKR0248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• 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): No
• Date Device Manufactured: 05/06/2025
• 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