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

Model Number	778624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
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.
Event or Problem Description
It was reported that they should open the guide wire package if the content was a broken tube.
Event or Problem Description
It was reported that they should open the guide wire package if the content was a broken tube.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted visual requirements state to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.When evaluating the sample, the separation was located on the distal pigtail.The material where the separation occurred does not appear to be stretched or discolored.An additional separation was evaluated at the suture porthole to the end of the stent.This is seen when the suture is forcefully pulled away from the stent.The suture was not provided for evaluation.The separated pigtail did have an indention in the tubing that appears similar to what is seen when the material is clamped for a period of time.The sample did appear to be slightly used due to the calcium buildup on part of the stent and the residue from the inside when the guidewire was performed.Dimensional requirements state the od is to be 0.079" ± 0.002", tip id to be 0.043" ± 0.002: guidewire to be 0.038" ± 0.001", and tube id to be 0.050" + 0.002" - 0.001." the sample passed all dimensional requirements.The od was measured at 0.0797" and 0.0798" 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 however there did appear to be foreign matter appeared when the guidewire exited the sample.The tube id where the separation occurred was measured using a 0.050" pin gauge.Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: "precautions: 1.For single use only.Do not resterilize.Do not use if the package or product is damaged.2.Improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period." 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® 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: 17312950
• Report Number: 1018233-2023-05105
• Device Sequence Number: 17142780
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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 Expiration Date: 08/17/2025
• Device Model Number: 778624
• Device Catalogue Number: 778624
• Device Lot Number: NGFR3525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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