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

Model Number	G15124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon opening the inner packaging, prior to a ureteral lithotomy surgery, the filiform double pigtail ureteral stent set's pigtail had completely fractured approximately one-fifth of the way of the stent's length.It was separated into two segments and rendering it unusable.A stent from another brand was substituted for the remainder of the procedure.A customer provided photo was provided that appears to show the tether attached and the stent is separated on the straight section of the stent tubing.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.
Additional Manufacturer Narrative
E1: phone: (b)(6).G4 - pma/510(k) #: preamendment 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: as reported, upon opening the inner packaging, prior to a ureteral lithotomy surgery, the filiform double pigtail ureteral stent set's pigtail had completely fractured approximately one-fifth of the way of the stent's length.It was separated into two segments and rendering it unusable.A stent from another brand was substituted for the remainder of the procedure.A customer provided photo was provided that appears to show the tether attached and the stent is separated on the straight section of the stent tubing.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Visual inspection of the returned complaint device was also conducted.The device was returned to cook for investigation in open packaging.The stent was in two pieces with the break occurring at a sideport.The tether was still intact on one of the segments.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 showed no discrepancies related to the reported failure mode.A complaint history search identified two other complaints reported for a related failure mode prior to use were recorded by the same facility.Due to the individual manufacturing nature of stents it is unlikely these failures are related.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: ¿precautions ¿ do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.¿ ¿how supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint could not be established.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.

• 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: 22978375
• Report Number: 1820334-2025-01108
• Device Sequence Number: 15810141
• Product Code: FAD
• UDI-Device Identifier: 00827002151246
• UDI-Public: (01)00827002151246(17)260428(10)15412313
• 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): 05/04/2026

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 Expiration Date: 04/28/2026
• Device Model Number: G15124
• Device Catalogue Number: 133726
• Device Lot Number: 15412313
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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