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

Model Number	787726
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
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.The device was not returned.
Event or Problem Description
It was reported that the urethral stent was found ruptured when the package was opened.It was also stated that the outer package of the product remained intact.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.A phot sample was provided by the customer which shows the stent broken into two pieces.The ureteral stent was returned with the opened original packaging.An evaluation was completed by futurematrix on 27oct2021.No evidence of stretching or discoloration was noted on the stent.The stent was observed to be separated and an additional mark was present next to the separation.The marks left at the separation could not be recreated other than being cut.The suture was removed from the stent and appeared to have been cut since there were no signs of stretching of the material.The stent passed dimensional requirements, with the outer diameter measuring at 0.093" and 0.092" using a laser micrometer, the tip inner diameter measuring at 0.043" using a pin gage, and the stent inner diameter measuring 0.048" using a pin gage at both ends where the disconnect occurred.A 0.038" guidewire was able to pass through the sample with no resistance.A potential root cause for this event could be, " inappropriate package design".No manufacturing issues or non-conformances were noted in the dhr that could have caused or contributed to the reported event; therefore, no additional action is required at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation." 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 found ruptured when the package was opened.It was also stated that the outer package of the product remained intact.

• 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 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12224211
• Report Number: 1018233-2021-04474
• Device Sequence Number: 11825983
• Product Code: FAD
• UDI-Device Identifier: 10801741015523
• UDI-Public: (01)10801741015523
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: Lay User/Patient
• Device Expiration Date: 01/10/2024
• Device Model Number: 787726
• Device Catalogue Number: 787726
• Device Lot Number: NGEN2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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