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

Model Number	G49874
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: line 2=(b)(6).E1: additional phone: (b)(6).E3: customer occupation = unknown.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
It was reported the universa firm ureteral stent set's stent was broken prior an unspecified procedure.The issue was found when the device was removed from the package and the user cut off the tether.The procedure was completed by using another same-like device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: it was reported the universa firm ureteral stent set's stent was broken prior an unspecified procedure.The issue was found when the device was removed from the package and the user cut off the tether.The procedure was completed by using another same-like device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device did not make patient contact.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), quality control (qc) procedures, as well as a visual inspection or the returned device were conducted during the investigation.One stent set was returned for investigation in an open package with label.Upon inspection the stent was in 2 pieces.The stent is separated at a sideport on the body of the stent.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 device history record (dhr) found no related non-conformances reported for this failure mode.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.The information provided upon review of complaint file, device history record, complaint history, quality control documents and complaint device do not provide evidence that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: the tether should be removed if the stent is to remain indwelling longer than 14 days.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint is likely inadvertent user error.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: 20456636
• Report Number: 1820334-2024-01332
• Device Sequence Number: 15402227
• Product Code: FAD
• UDI-Device Identifier: 00827002498747
• UDI-Public: (01)00827002498747(17)270205(10)15882751
• Combination Product (Y/N): N
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Model Number: G49874
• Device Catalogue Number: UFH-626
• Device Lot Number: 15882751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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
• Patient Sex: Unknown