MAUDE Adverse Event Report: Cook Ireland Ltd GEENEN PANCREATIC STENT SET; FGE - Stents, Drains And Dilators For The Biliary Ducts

Model Number	G21803
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The doctor was unable to fit the prosthesis into the canal.It detached and fell into the digestive tract, unfortunately not recoverable.The practitioner deployed the stent in bad position and lost the stent in the duodenum.The doctor did not succeed in properly inserting the stent into the canal.It detached and fell into the digestive tract; unfortunately, it cannot be retrieved.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 24-aug-2026.
Additional Manufacturer Narrative
Supplemental report is being submitted due to the completion of the investigation on 24-aug-2026.Investigation - evaluation device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document based investigation was conducted.The sales representative queried why a product complaint was being raised for this issue as they stated that it was a user handling issue that led to the stent being accidently deployed in the duodenum.However, it was relayed to them that there was still migration of the stent which is a device malfunction and requires a full investigation, regardless of the handling error.Manufacturing records: prior to distribution, all gpds-5-5 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for the gpds-5-5 device of lot number c2218547 did not reveal any discrepancies that could have contributed to this complaint issue.A nc (non-conformance) was noted in production for rough material but this was subsequently scrapped and did not contribute to the reported issue.Review historical data: a review of the manufacturing records for the gpds-5-5 device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2218547.Instructions for use and label: as per the instructions for use (ifu0055), which informs the user about the potential complications that may occur: "those associated with pancreatic stent placement include, but are not limited to: trauma to the pancreatic tract or duodenum, obstruction of the common bile duct, stent migration." there is no evidence to suggest that the customer did not follow the instructions for use.(ifu0055) image review: medical imaging (e.G.Mri, ct, x-ray) was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause may be attributed to user handling during stent placement which may have contributed to suboptimal stent deployment and subsequent migration of the stent into the duodenum.However, as stated in the instructions for use, migration is a known adverse event associated with this device.Clinical input received stated that the stent migrated distally into the duodenum and had advanced too far to be retrieved although a migrated pancreatic stent does not necessarily need to be retrieved and in most cases is expelled naturally.Several requests were made for additional information but it was not forthcoming, if it is received at a later date the investigation 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 similar events.Summary of investigation: according to the customer, the doctored deployed the stent in a bad position and lost the stent in the duodenum.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient outcome was unknown.Investigation findings conclude that a definitive root cause could not be determined from the available information.A possible root cause may be attributed to user handling during stent placement which may have contributed to suboptimal stent deployment and subsequent migration of the stent into the duodenum.However, as stated in the instructions for use, migration is a known adverse event associated with this device.Clinical input received stated that the stent migrated distally into the duodenum and had advanced too far to be retrieved although a migrated pancreatic stent does not necessarily need to be retrieved and in most cases is expelled naturally.Several requests were made for additional information but it was not forthcoming, if it is received at a later date the investigation will be updated accordingly.

• Brand Name: GEENEN PANCREATIC STENT SET
• 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 V94 N 8X2; EI V94 N8X2
• Manufacturer (Section G): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick V94 N-8X2 ; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 25881373
• Report Number: 3001845648-2026-00298
• Device Sequence Number: 8046891
• Product Code: FGE
• UDI-Device Identifier: 00827002218031
• UDI-Public: (01)00827002218031(17)270927(10)C2218547
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K900923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Model Number: G21803
• Device Catalogue Number: GPDS-5-5
• Device Lot Number: C2218547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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
• Patient Sex: Unknown