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

Model Number	G15145
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a stone removal procedure, the stents from two filiform double pigtail ureteral stent sets were unable to advance over the wireguide.The procedure was completed by using a universa soft stent.The two stents that were unable to advance over the wireguide had different lot numbers.Reference patient identifier (b)(6) (this report) for stent # 1, and reference patient identifier (b)(6) for the stent # 2.A third stent was attempted to be used, however, the surgeon mistakenly used a stent that was too short, then removed it.The procedure was complete by using a 4th stent which was a universa soft stent.As section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.No patient adverse effects have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 ¿ pma/510(k) #: preamendment.H3: device has not yet been returned to manufacturer; however, our investigation is ongoing, and device evaluation summary will be included in our follow up report once our investigation has been completed.H10- related report numbers: (b)(4).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
Corrected information: d4 - lot # additional information: h10.Investigation ¿ evaluation.Event description: during a stone removal procedure, the stents from two filiform double pigtail ureteral stent sets were unable to advance over the wireguide.The procedure was completed by using a universa soft stent.The two stents that were unable to advance over the wireguide had different lot numbers.Reference this report for stent # 1 and reference mdr # 1820334-2025-00501 for the stent # 2.A third stent was attempted to be used, however, the surgeon mistakenly used a stent that was too short, then removed it.The procedure was complete by using a 4th stent which was a universa soft stent.As section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.No patient adverse effects have been reported.Functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, instructions for use (ifu) and quality control procedures.Two filiform double pigtail ureteral stents were returned for analysis.There was no way to distinguish which stent was from which lot.Both stents were loaded onto a stock 0.035 wire guide and advanced without difficulty.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 found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The information provided upon review of the complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.The instructions for use (ifu) contains the following information related to 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.The cause of the deployment difficulty was not able to be determined for this incident per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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.

• 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: 21996498
• Report Number: 1820334-2025-00500
• Device Sequence Number: 19955108
• Product Code: FAD
• UDI-Device Identifier: 00827002151451
• UDI-Public: (01)00827002151451(17)270221(10)15909640
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: G15145
• Device Catalogue Number: 133624
• Device Lot Number: 15909640
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK UROSTREAM WIRE; SENSOR WIRE FROM BOSTON
• Patient Sex: Unknown