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

Catalog Number	787622
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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.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 the urethral stent was bending.The pigtail was bent near the tip before use.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The product had caused the reported failure.Sample has been evaluated and observed that the pigtail of stent was slightly bent.No black suture returned for evaluation.The complaint has been confirmed, however the exact cause on how and when problem occurred could not be determine.A potential root cause for this failure mode could be, ¿defect components from supplier¿.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.The instructions for use were found adequate and state the following: single use only.Warnings 1.Method for use (1) when using the multi-length type stent, it should be avoided in the following cases.1) if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear, consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil parts have risks of knot formation at the tip of renal pelvis side during placement or removal.2) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter.(2) ureteroarterial fistula may be formed between the ureter and the aorta or the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care.Correction: d, f, 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 the urethral stent was bending.The pigtail was bent near the tip before use.

• 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: 22394792
• Report Number: 1018233-2025-05460
• Device Sequence Number: 9061080
• Product Code: FAD
• UDI-Device Identifier: 10801741015424
• UDI-Public: (01)10801741015424(11)241123(17)271028(10)MYJW4320
• 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): 08/20/2025

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: 787622
• Device Lot Number: MYJW4320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2024
• 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