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

Model Number	G21707
Medical Device Problem Codes	Dent in Material (2526); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor wanted to insert zso-7-10 into the cbd through the prepositioned (visiglide 2 0.025 straight) wire guide, assistant nurse tried to straighten the zso-7-10 using a straightener.The nurse straightened zso's pigtail and passed a wire through, but the wire did not pass.The wire did not pass because the pigtail was bent.The new zso-7-10 was used.And wire guide was not changed.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 17-oct-2025.
Additional Manufacturer Narrative
Device evaluation: the device evaluation of zso-7-10 of c2199784 lot number could not be completed as the device or photographic evidence was not returned for evaluation.Manufacturing records review: prior to distribution, all the devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for zso-7-10 of c2199784 lot number 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 review: as per the instructions for use¿s notes section, 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, "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." there is evidence to suggest that the customer did not follow the instructions for use.It is also known that a 0.025 inch wire guide was attempted to be used with the device.Additionally, from the information received, it is also known that the 0.025 inch wire guide was also used with the replacement device used to complete the procedure successfully.However, based on the available information, it appears that the stent was already bent before it was loaded onto the wire guide.As per management of complaints procedure where information is reviewed and categorized as use related/off label use and where no adverse event is identified then no complaint is required.The event is documented in the pms tracker and reviewed as part of post market surveillance¿.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.Based on the information provided they used a straightener to unfold the pigtail section and inserted the guide wire, but the wire did not pass through as the pigtail section bent at the tip.Hence the possible root cause could be attributed to the kink occurring while it was being straightened as it was being loaded onto the wire guide.Confirmation of complaint: the 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: confirmed quantity of 1 device, confirmed used.A definitive root cause could not be determined from the available information.Based on the information provided a possible root cause could be attributed to the kink occurring while it was being straightened as it was being loaded onto the wireguide.The complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, no health consequences or impacts were reported.The complaint occurred during device preparation and did not make contact with the patient.Another zso-7-10 device was used to complete the procedure.Complaints of this nature will continue to be monitored for similar events.

• Brand Name: ZIMMON 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: 22893552
• Report Number: 3001845648-2025-00430
• Device Sequence Number: 15699456
• Product Code: FGE
• UDI-Device Identifier: 00827002217072
• UDI-Public: (01)00827002217072(17)270731(10)C2199784
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: G21707
• Device Catalogue Number: ZSO-7-10
• Device Lot Number: C2199784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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