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	11/25/2025
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: 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 the patient underwent right nephrolithotripsy with holmium laser lithotripsy via ureteroscope and right ureteral stent placement.A ureteral stent was placed intraoperatively.The procedure proceeded smoothly with unobstructed drainage.One month later, the patient returned as instructed for ureteral stent removal.Intraoperatively, extensive calculus adhesion was observed on the stent surface.Holmium laser lithotripsy was performed to remove the ureteral stones and extract the stent, resulting in bleeding.Solution: holmium laser lithotripsy was performed to remove most of the stones adhering to the ureteral stent.The intact stent was then extracted using foreign body forceps.Surgical intervention was performed.
Event or Problem Description
It was reported that the patient underwent right nephrolithotripsy with holmium laser lithotripsy via ureteroscope and right ureteral stent placement.A ureteral stent was placed intraoperatively.The procedure proceeded smoothly with unobstructed drainage.One month later, the patient returned as instructed for ureteral stent removal.Intraoperatively, extensive calculus adhesion was observed on the stent surface.Holmium laser lithotripsy was performed to remove the ureteral stones and extract the stent, resulting in bleeding.Solution: holmium laser lithotripsy was performed to remove most of the stones adhering to the ureteral stent.The intact stent was then extracted using foreign body forceps.Surgical intervention was performed.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-video sample noted one opened (without original packaging), used ureteral stent.Visual inspection of the video sample noted an image captured from the video, which also depicted the stent with calcification.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab 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 WITH NICORE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• 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: 23717293
• Report Number: 1018233-2025-10767
• Device Sequence Number: 16052627
• Product Code: FAD
• UDI-Device Identifier: 10801741014274
• UDI-Public: (01)10801741014274(11)250605(17)300226(10)NGKS2238
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/24/2026

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: NGKS2238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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