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

Catalog Number	777426
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2025
Type of Reportable Event	Malfunction
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, during the preoperative procedure, when opening the ureteral stent and advancing the guidewire, the stent tube became obstructed, preventing the guidewire from passing through.However, the newly deployed stent allowed the guidewire to pass smoothly.
Event or Problem Description
It was reported, during the preoperative procedure, when opening the ureteral stent and advancing the guidewire, the stent tube became obstructed, preventing the guidewire from passing through.However, the newly deployed stent allowed the guidewire to pass smoothly.
Additional Manufacturer Narrative
The reported event was unconfirmed.Stent tubing was visually inspected.Tubes must be free of lumps, flat spots, voids, or other deformities.No embedded or loose foreign matter in excess of an aggregated total of 0.3mm2.Eyes must be cleanly punched with no loose materials, excessive ragged edges, or plugged eyes allowed.No defects were noted.Stent tubing was inspected dimensionally for tip id and functionally for guide wire passage per customer specification and customer drawing.Tip id was measure with 0.037 inches minus pin gauge and 0.035 inches guidewire passage was performed 0.035 inches guidewire.Both allowed free passage and smooth insertion and removal.The reported event was unconfirmed.Risk, labelling, and dhr review are not required as the reported event was unconfirmed.No additional actions can be taken at this time.Corrections: d, e, 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 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: 23073666
• Report Number: 1018233-2025-08238
• Device Sequence Number: 4645655
• Product Code: FAD
• UDI-Device Identifier: 10801741014489
• UDI-Public: (01)10801741014489(11)240910(17)290531(10)NGJV1953
• 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): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 777426
• Device Lot Number: NGJV1953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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