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

Model Number	G22150
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor intended to use ttso-8.5-13 along with oa-8.5 for drainage in the cbd stricture area.As usual, ttso-8.5-13 was preloaded into oa-8.5 and approached into the cbd.The inner guiding catheter was positioned along the wire, but during the process of inserting the stent, the inner guiding catheter did not separate well and the sheath stretched.There was significant resistance, and after much difficulty, ttso-8.5-13 was positioned, and the inner guiding catheter was separated to complete the procedure.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation.1 unit of oa-8.5 of lot number c2229618 device was not returned for evaluation.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records review: prior to distribution all the devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use/label: as per the instructions for use¿s notes section (ifu0096 & ifu0045), which accompanies this device, instructs the user to inspect the device prior to use: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".As per the precautions section of the instructions for use (ifu0096 & ifu0045), which accompanies this device, "refer to package label for minimum channel size required for this device." and "wire guide diameter and inner lumen of wire-guided device must be compatible." the product label states the guide wire size for use with this device is 0.035".It is known that a 0.025 inch wire guide was used with the device.There is evidence to suggest the user did not follow the ifu/label.Image review.An image was not returned for evaluation.Root cause review: a definitive root cause of use error was established.The user has not complied with the requirements of the ifu and/or label.From the information available, the user used a 0.025-inch wire guide instead of the required 0.035-inch wire guide.Use of thinner wire guide (0.025¿) would provide reduce support and increased risk of catheter deformation under resistance.Thinner wire guide offers less column strength which resulted in inadequate support during guiding catheter advancement and increased chances of buckling of the catheter if resistance is encountered.The catheter may twist or stretch more easily if the wire guide does not provide sufficient guidance or stiffness.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Corrective action/correction: capa 387756 has been initiated from complaints related to user error in practice a 0.025¿ wire guide is being used.Summary: confirmed qty of devices: 01 device confirmed used.Complaint is confirmed based on customer and/or rep testimony.Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu and/or label.From the information available, the user used a 0.025-inch wire guide instead of the required 0.035-inch wire guide.Use of thinner wire guide (0.025¿) would provide reduce support and increased risk of catheter deformation under resistance.Thinner wire guide offers less column strength which resulted in inadequate support during guiding catheter advancement and increased chances of buckling of the catheter if resistance is encountered.The catheter may twist or stretch more easily if the wire guide does not provide sufficient guidance or stiffness.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 03-sep-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: 22561895
• Report Number: 3001845648-2025-00338
• Device Sequence Number: 17119504
• Product Code: FGE
• UDI-Device Identifier: 00827002221505
• UDI-Public: (01)00827002221505(17)271025(10)C2229618
• 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): 09/03/2025

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: G22150
• Device Catalogue Number: OA-8.5
• Device Lot Number: C2229618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• 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