MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G25381
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When releasing the biliary prosthesis from the introducer, the prosthesis locked and became damaged, impairing and rendering the material unusable.No unintended section of this device remain inside the patient¿s body.The patient was not hospitalized and did not undergo prolonged hospitalization due to this occurrence.The patient did not experience a delay or require any additional procedure due to this occurrence.The complainant did not report any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Device evaluation: 01 x oacl-10-9 device of lot number c2249312 involved in this complaint was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing record review: prior to distribution all oacl-10-9 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for oacl-10-9 of lot number c2249312 did not reveal any discrepancies that could have contributed to this complaint issue.Review of 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: the instructions for use, which accompanies this device instructs the user to ¿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.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.A possible root cause could be attributed to excessive force applied with the pushing catheter during stent introduction into the target location that led to the stent becoming damaged and stuck within the scope, consequently, during the attempted release, the stent may have locked.Subsequent efforts to unlock the stent using additional tools could have contributed to damage of the stent.Additional information in the patient/event info - notes confirmed that the stent became stuck inside the work channel of the scope during deployment, preventing its release.It is also possible that the flap of the stent became caught in the accessory of the scope as it was being advanced through resulting in the flap become bent/damaged and subsequently impacting the release of the stent from the scope.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: confirmed quantity of 1 device, confirmed used.Investigation findings conclude that a definitive root cause could not be determined.A possible root cause could be attributed to excessive force applied with the pushing catheter during stent introduction into the target location that led to the stent becoming damaged and stuck within the scope, consequently, during the attempted release, the stent may have locked.Subsequent efforts to unlock the stent using additional tools could have contributed to damage of the stent.Additional information in the patient/event info - notes confirmed that the stent became stuck inside the work channel of the scope during deployment, preventing its release.It is also possible that the flap of the stent became caught in the accessory of the scope as it was being advanced through resulting in the flap become bent/damaged and subsequently impacting the release of the stent from the scope.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 21-oct-2025.

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• 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: 22836191
• Report Number: 3001845648-2025-00408
• Device Sequence Number: 15805102
• Product Code: FGE
• UDI-Device Identifier: 00827002253810
• UDI-Public: (01)00827002253810(17)271217(10)C2249312
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 10/21/2025

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: G25381
• Device Catalogue Number: OACL-10-9
• Device Lot Number: C2249312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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 Age: 69 YR
• Patient Sex: Female