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

Model Number	G46443
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there have been issues with stent breakage for the past few months/weeks regarding the black silicone filiform double pigtail ureteral stent.The facility is required to remove the double j stents a few weeks post-transplant surgery and have had to modify their removal techniques recently to minimize this occurrence.The physicians performing most of the removals have been residents.Recently, the initial reporter removed a stent without any problems.After removal it was found the stent was very resistant to breakage, suggesting that the issue might be related to the residents' inexperience.However, upon removal of another stent without issue, this stent was found to be very fragile and broke apart with minimal effort.There has been no information regarding patient adverse effects.It has been reported no additional case specific information will be provided.
Additional Manufacturer Narrative
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d9.Investigation ¿ evaluation.It was reported there have been issues with stent breakage for the past few months/weeks regarding the black silicone filiform double pigtail ureteral stent.The facility is required to remove the double j stents a few weeks post-transplant surgery and have had to modify their removal techniques recently to minimize this occurrence.The physicians performing most of the removals have been residents.Recently, the initial reporter removed a stent without any problems.After removal it was found the stent was very resistant to breakage, suggesting that the issue might be related to the residents' inexperience.However, upon removal of another stent without issue, this stent was found to be very fragile and broke apart with minimal effort.There has been no information regarding patient adverse effects.It has been reported no additional case specific information will be provided.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.Functional tests and visual inspection of the returned complaint devices were also conducted.Five devices were returned for investigation, and all were stretched and bent with no issues.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 lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, cook has concluded that the device was manufactured to specification and that there is no evidence that nonconforming product exists in house or in 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 devices, 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: 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: 21968687
• Report Number: 1820334-2025-00479
• Device Sequence Number: 15573469
• Product Code: FAD
• UDI-Device Identifier: 00827002464438
• UDI-Public: (01)00827002464438(17)280128(10)16439802
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: G46443
• Device Catalogue Number: 133620-01
• Device Lot Number: 16439802
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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