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

Catalog Number	788414
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 that the stent was unable to advance on the guide wire.It may be a problem with an excessive resistance during stent delivery.Per additional information received via ibc on 19mar2025, stated that they tried about 3 times to advance the stent over the guidewire, but they failed.
Additional Manufacturer Narrative
The reported event is inconclusive.Visual evaluation noted rhe sample was provided with the original bard inlay pouch and placed inside a large ziploc bag.The suture and pigtail straightener were not provided.Visual requirements per cs-7505-xx section 3.1 state to "use unaided eye at 12" to 18" distance under normal room lighting, unless otherwise noted.Dimensional requirements per cd-7505-xx state the od of the stent is to be 0.061" ± 0.002", and the guidewire used is to be 0.035" ± 0.001".Upon evaluaiton, no visual defects were observed.The outer diamter (od) was measured at 0.0623", using a laser micrometer.A 0.035" guidewire was passed through the sample without resistance.Based on this assessment, the reported issue regarding guidewire passage cannot be confirmd.It should be noted that the suture and pigtail straightener were not included with the returned sample and therefore could not be evaluated.Additionally, the guidewire used during the original procedure was not provided for assessment.Also received 2 photo samples.First photo sample shows top view of stent and pusher within packaging.Second photo sample shows top view of product packaging and document written in native language.As guidewire was not received and it is unknown how the product interacted with the patient's body the reported event is inconclusive.Instructions for use were reviewed for this investigation.The labelling was reviewed and found to be adequate.Dhr review did not show any problems or conditions that would have contributed to the reported event.Corrections: d, 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.
Event or Problem Description
It was reported that the stent was unable to advance on the guide wire.It may be a problem with an excessive resistance during stent delivery.Per additional information received via ibc on 19mar2025, stated that they tried about 3 times to advance the stent over the guidewire, but they failed.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• 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: 21762760
• Report Number: 1018233-2025-02300
• Device Sequence Number: 18323070
• Product Code: FAD
• UDI-Device Identifier: 00801741015649
• UDI-Public: (01)00801741015649(11)240301(17)280822(10)NGJN2743
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 788414
• Device Lot Number: NGJN2743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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