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

Catalog Number	776626
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent ureteroscopic laser lithotripsy and left ureteral stent placement.The procedure was smooth, and the internal stent drained well.One month later, the patient returned as instructed for planned stent removal.Intraoperatively, a large amount of stone adhered to the entire surface of the renal pelvic end of the ureteral stent, preventing its removal.Holmium laser lithotripsy was performed to remove most of the stones on the ureteral stent, and the stent was completely removed from the ureter using foreign body forceps.
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: 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.
Additional Manufacturer Narrative
The reported event is confirmed - cause unknown.Video sample evaluation: visual review of the video sample shows the patient in the operating room, with the display indicating a large amount of stone adhered to the entire surface of the renal pelvic end of the ureteral stent.Therefore, the 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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 a female patient underwent ureteroscopic laser lithotripsy and left ureteral stent placement.The procedure was smooth, and the internal stent drained well.One month later, the patient returned as instructed for planned stent removal.Intraoperatively, a large amount of stone adhered to the entire surface of the renal pelvic end of the ureteral stent, preventing its removal.Holmium laser lithotripsy was performed to remove most of the stones on the ureteral stent, and the stent was completely removed from the ureter using foreign body forceps.

• Brand Name: BARD® INLAY® URETERAL STENT WITH NICORE¿ 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24157803
• Report Number: 1018233-2026-00221
• Device Sequence Number: 18408818
• 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): 05/13/2026

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: 776626
• Device Lot Number: NGKS3068
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/08/2026
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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; Required Intervention
• Patient Sex: Female