MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G15146
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 - pma/510(k)#: pre-amendment.H3 - device evaluated by mfg: device was returned and remains under investigation.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, prior to an unspecified procedure, one pigtail end of the stent included in the 'filiform double pigtail ureteral stent' was found to be broken.The issue was discovered by the physician during the pre-operative examination upon opening the packaging.The procedure was completed successfully using another new stent.The device did not make patient contact.The patient did not require any additional procedures or experience any adverse effects due to this event.

• Brand Name: FILIFORM DOUBLE PIGTAIL 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: 23794613
• Report Number: 1820334-2025-01548
• Device Sequence Number: 10465285
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)280707(10)16680796
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 06/05/2026

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: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 16680796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INNOVISION FLEXIBLE ENDOSCOPE.; KEMEIREN FIBER OPTICS.
• Patient Sex: Unknown