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

Catalog Number	787626
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2025
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 during stent use the black tip, end point came off and fell into the ureter during insertion of the ureteral catheter.As per additional information received on 21apr2025, it was retrieved immediately during surgery, so no additional procedures were performed.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The product had caused the reported failure.Sample has been evaluated and observed the black tip of guidewire was detached.This complaint was confirmed; however, scar issuance would not be initiated since the adverse trend of complaints reported was not exceeded threshold for 1069 -device breakage.However, communication have been sent to supplier to address this issue.A potential root cause for this failure mode could be, ¿defect components from supplier¿.Pfmea ra87p041 rev 14 (packaging and cartoning of tripak) was reviewed for this investigation and has addressed in step/item#1.A potential root cause for this failure mode could be, ¿defect components from supplier¿.Based on information in the fmea, the risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.A review of the device labelling has been conducted for investigation purposed.The ifu is attached in the investigation overview tab.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore, no additional action required at this time.Correction: d, e, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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 during stent use the black tip, end point came off and fell into the ureter during insertion of the ureteral catheter.As per additional information received on 21apr2025, it was retrieved immediately during surgery, so no additional procedures were performed.

• Brand Name: BARD® INLAY OPTIMA® 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22070675
• Report Number: 1018233-2025-03791
• Device Sequence Number: 18292750
• Product Code: FAD
• UDI-Device Identifier: 10801741015448
• UDI-Public: (01)10801741015448(11)250117(17)271128(10)MYJY3039
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 787626
• Device Lot Number: MYJY3039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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