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

Model Number	G46439
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone number: (b)(6).H3: 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
It was reported during a retrograde intrarenal surgery (rirs) with stent replacement.During the removal of the black silicone filiform double pigtail ureteral stent, the surgeon found that one side of the tip was broken.The stent had been placed less than two months ago.Another device and forceps clamp was used to remove the broken stent and another same stent was placed to complete the procedure without difficulties.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d4 - lot #, d4 - expiration date, d4 - primary udi number, d9, h4 - device mfg date h3: device evaluated by mfg = other (81) -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
Additional information: the device was returned 08dec2025 with a lot number.No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT
• 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: 23689420
• Report Number: 1820334-2025-01484
• Device Sequence Number: 9124317
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K172017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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: G46439
• Device Catalogue Number: 133624-01
• Device Lot Number: 16618044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 05/20/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/17/2025; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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: Unknown