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

Catalog Number	788726
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after unpacking, it was found that the stent was creased and could not be used.The silk thread was not removed, and the stent did not enter the human body.Open a new stent for use.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.Visual evaluation noted the sample was provided with the original bard inlay pouch inside a large ziploc bag.The suture was not provided.Visual requirements per cs-7090-xx state to use unaided eye at 12" to 18" under normal room lighting unless otherwise noted.When evaluating the sample there could no defects seen.The suture was not provided with the sample, the complaint reports the suture "was not removed".It should be noted that the stents are bulk packaged by biomerics and bducc performs further packaging.Dimensional evaluation noted the sample passed all dimensional requirements per cd-7090-xx.Dimensional requirements per cd-7090-xx state the od to be 0.091" ± 0.002", tip id 0.043" ± 0.002", and guidewire to be 0.038" ± 0.001".The od of the sample was measured at 0.0920" using a laser micrometer.The tip id was measured using a 0.043" pin gauge.A 0.038" guidewire passed through the sample with no hesitation.Also received 1 photo sample that shows top view of stent with circle indicating location of crease.However, upon visual inspection no visual defect was noted in the photo sample received.Based on the photo and physical sample received the reported event is unconfirmed.A risk, labelling and device history record review was not required as the reported event was unconfirmed.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 after unpacking, it was found that the stent was creased and could not be used.The silk thread was not removed, and the stent did not enter the human body.Open a new stent for use.

• 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 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19781747
• Report Number: 1018233-2024-04368
• Device Sequence Number: 8110823
• Product Code: FAD
• UDI-Device Identifier: 00801741015847
• UDI-Public: (01)00801741015847(11)221106(17)261124(10)NGGX2864
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• 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): 10/17/2024

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: 788726
• Device Lot Number: NGGX2864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2022
• 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