MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G23404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Initial reporter occupation: perioperative supply chain manager.Device evaluated by mfr: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, a universa soft ureteral stent was damaged.A universa firm ureteral stent set (per device packaging returned with the device) was received 24jan2023 with a small section of the stent missing.There were no adverse effects to the patient reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
Event description as reported, a universa soft ureteral stent was damaged.A universa firm ureteral stent set (per device packaging returned with the device) was received 24jan2023 with a small section of the stent missing.Multiple requests for additional information regarding the incident, such as the patient/procedural outcome, were sent to the customer.No reply was received despite due diligence on cook¿s part.There were no adverse effects to the patient reported.Investigation ¿ evaluation reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu), as well as a visual inspection of the returned device were conducted during the investigation.One device was returned in an open package with label.Upon inspection the stent was highly discolored and had some encrustation.A small section of the stent also was noted to be missing from the proximal end.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A complaint database search did not identify any other complaints associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_uss_rev5] ¿universa soft ureteral stents and stent sets¿ contains the following information related to the reported failure mode.¿precautions¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered¿ ¿potential adverse events¿encrustation¿ ¿how supplied¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, the cause of the break was not able to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16372102
• Report Number: 1820334-2023-00127
• Device Sequence Number: 6757232
• Product Code: FAD
• UDI-Device Identifier: 10827002234045
• UDI-Public: (01)10827002234045(17)250808(10)14883733
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 08/08/2025
• Device Model Number: G23404
• Device Catalogue Number: UFH-622-RT1
• Device Lot Number: 14883733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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
• Patient Sex: Unknown