MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G14898
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 'sof-flex pediatric double pigtail ureteral stent' was placed on (b)(6) 2024 for treatment of a pelvic tumor and hydronephrosis.The patient was discharged home but returned on (b)(6) 2024 due to the stent protruding from urethral meatus.The patient returned to the operating room where it was noted that the device had separated; the surgeon used a ureteroscope to check for any remaining stent fragments in the urethra and kidney.It was reported that the remaining pieces of the stent were removed.A replacement stent was placed and the patient was hospitalized for an additional day.The device did not perforate any part of the patient's anatomy.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = k180053.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
Investigation ¿ evaluation.It was reported that a 'sof-flex pediatric double pigtail ureteral stent' was placed on (b)(6) 2024 for treatment of a pelvic tumor and hydronephrosis.The patient was discharged home but returned on (b)(6) 2024 due to the stent protruding from urethral meatus.The patient returned to the operating room where it was noted that the device had separated; the surgeon used a ureteroscope to check for any remaining stent fragments in the urethra and kidney.It was reported that the remaining pieces of the stent were removed.A replacement stent was placed and the patient was hospitalized for an additional day.The device did not perforate any part of the patient's anatomy.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.The complaint device was not returned; therefore, no physical examinations could be performed.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 (dhr) found no related non-conformances reported for the failure mode.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.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 components during removal or replacement.Carefully remove the components if any resistance is encountered.Improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress¿angulation of the wire guide or stent should be avoided.How supplied: upon removal from the package, inspect the product to ensure no damage has occurred." based upon the available information, no product returned, 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.
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: SOF-FLEX PEDIATRIC 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: 20334071
• Report Number: 1820334-2024-01283
• Device Sequence Number: 15487873
• Product Code: FAD
• UDI-Device Identifier: 00827002148987
• UDI-Public: (01)00827002148987(17)250912(10)14951501
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2025
• Device Model Number: G14898
• Device Catalogue Number: 039514
• Device Lot Number: 14951501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 MO
• Patient Sex: Female