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

Catalog Number	788614
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
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.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 the circulating nurse opened the package, the hand-washing nurse took the stent out of the package.After cutting the tail thread as instructed by the doctor, they found that the indwelling stent was bent in one place.After the circulating nurse confirmed that it was unusable, they put it back.
Event or Problem Description
It was reported that after the circulating nurse opened the package, the hand-washing nurse took the stent out of the package.After cutting the tail thread as instructed by the doctor, they found that the indwelling stent was bent in one place.After the circulating nurse confirmed that it was unusable, they put it back.
Additional Manufacturer Narrative
The reported event is unconfirmed.Visual: the sample was provided with the original bard inlay box and pouch and placed inside a large ziploc bag.Visual requirements per cs-7505-xx state to use unaided eye at 12" to 18" under normal room lighting unless otherwise noted.Dimensional requirements per vd-7505-xx state the od to be 0.079" ± 0.002", tip id 0.043" ± 0.002", and guidewire to be 0.038" when evaluating the sample, it could be seen that the suture and pigtail straighter had been removed from the sample.A defective bend that was reported could be located, other that what would be the form the stent takes after being packaged for a period of time.The form did restrict the use of the sample.The sample passed the dimensional requirements per cd-7505-xx.The od measured at 0.0801" using laser micrometer.The id was measured using a 0.043" pin gauge.A 0.038" guidewire passed thorough the sample without any hesitation.Also received 2 photo samples.First photo sample shows top view of catheter on product packaging.Second photo sample shows zoomed in location of potential bend.Based on photo and physical sample received the reported event is unconfirmed.No root cause could be found because the reported event was unconfirmed.Risk, labelling, and dhr review is not required as the reported event is unconfirmed.Correction: 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.

• 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, GA 30014 ; 7707846100
• MDR Report Key: 20189625
• Report Number: 1018233-2024-05696
• Device Sequence Number: 7113196
• Product Code: FAD
• UDI-Device Identifier: 00801741015724
• UDI-Public: (01)00801741015724(11)240423(17)280629(10)NGJN0560
• 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): 01/07/2025

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: 788614
• Device Lot Number: NGJN0560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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