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

Model Number	G49866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported, an universa firm ureteral stent set was found "broken" inside the unopened package, prior to patient contact for an unknown procedure involving the kidney.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.A5: ethnicity = chinese.H3: device evaluated by mfg: device evaluation anticipated, but not yet begun.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
Additional information received: procedure was completed with a new device.It is unknown how the stent was broken.
Additional Manufacturer Narrative
Additional information: b5.D9 - device received but remains under investigation.Correction: g4 - combination product.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.
Additional Manufacturer Narrative
Summary of event: it has been reported, an universa firm ureteral stent set was found "broken" inside the unopened package, prior to patient contact for an unknown procedure involving the kidney.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information received 04mar2026: procedure was completed with a new device.It is unknown how the stent was broken.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.The complaint device was returned to cook for investigation.The product was returned in open original packaging despite the customer description of the device not being opened.The wire guide was returned in unopened packaging.One stent pigtail coil had fully separated from the body of the stent.The tether was returned but no longer on the stent and potentially severed in its removal from the stent.No damage was noted on the positioner.Due to the customer description and the return of the device in open packaging, it is unclear what caused the coil to separate from the stent.A review of the device history record (dhr) and complaint history found no discrepancies or additional relevant complaints on the lot.The product ifu contains the following information related to the reported failure mode: precautions: do not force components during removal or replacement.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Based on the information provided and the results of the investigation, cook has concluded that a cause for the reported failure mode could not be established.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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: 22862683
• Report Number: 1820334-2025-01043
• Device Sequence Number: 9359235
• Product Code: FAD
• UDI-Device Identifier: 00827002498662
• UDI-Public: (01)00827002498662(17)280411(10)16553670
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 04/28/2026

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: G49866
• Device Catalogue Number: UFH-526
• Device Lot Number: 16553670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 03/04/2026; 03/31/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 03/23/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian