MAUDE Adverse Event Report: COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G21469
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
F5 - phone number: (b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When doctor inserted stent into cbd, stent was not inserted.
Additional Manufacturer Narrative
F5 - phone number: (b)(6).Device evaluation: 1 unit of lot c2122148 of clso-10-7 device could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution, all clso-10-7 devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for clso-10-7 of lot number c2122148 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and label: instructions for use (ifu0045), which accompanies this device, instructs the user: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.(ifu0045) image review: an image was not returned for evaluation.Root cause review: a definitive cause could not be determined from the investigation.A possible root cause could be attributed to the handling technique and the stent not being inserted into the target location.The stent might have been placed inaccurately, due to which the doctor was not able to push it through the intended location.There have been several attempts made to obtain additional information.Should additional information be made available, the file will be updated accordingly.Confirmation of complaint: complaint is confirmed based on customer and /or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: confirmed quantity of 1 device, confirmed used.Complaint is confirmed based on customer and /or rep testimony.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive cause could not be determined from the investigation.A possible root cause could be attributed to the handling technique and the stent not being inserted into the target location.The stent might have been placed inaccurately, due to which the doctor was not able to push it through the intended location.There have been several attempts made to obtain additional information.Should additional information be made available, the file will be updated accordingly.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 28-oct-2025.

• Brand Name: COTTON-LEUNG BILIARY STENT
• Common Device Name: FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23399534
• Report Number: 3001845648-2025-00542
• Device Sequence Number: 10047085
• Product Code: FGE
• UDI-Device Identifier: 00827002214699
• UDI-Public: (01)00827002214699(17)261207(10)C2122148
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: G21469
• Device Catalogue Number: CLSO-10-7
• Device Lot Number: C2122148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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