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	09/12/2025
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
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
Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all zso-7-10 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zso-7-10 of lot number c2304468 did not reveal any discrepancies that could have contributed to this complaint issue.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2304468.Review historical data: a review of the manufacturing records for the zso-7-10 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 c2304468.Instructions for use and label: as per the instructions for use notes section (ifu0045) which accompanies this device instructs the user to inspect the device: "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 (ifu0045), which accompanies this device, "refer to package label for minimum channel size required for this device." 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.It is also known from the available information that the incorrect wire guide was used with the replacement device to complete the procedure.¿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.A possible root cause could be attributed to the kink occurring while the pigtail was being straightened with the pigtail straightener prior to being loaded onto the wire-guide.As per the description of event, the wire was unable to pass through the stent which supports the claim that the kink had already occurred due to the straightening process.Several requests were made of made for additional information but it was not forthcoming, if it received at a later date then the investigation will be updated accordingly.Confirmation of complaint: complaint is confirmed based on customer/rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the report, the pigtail part of the stent was bent.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the kink occurring while the pigtail was being straightened with the pigtail straightener prior to being loaded onto the wire-guide.As per the description of event, the wire was unable to pass through the stent which supports the claim that the kink had already occurred due to the straightening process.Several requests were made of made for additional information but it was not forthcoming, if it received at a later date then the investigation will be updated accordingly.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on (b)(6) 2025.

• 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: 23270821
• Report Number: 3001845648-2025-00504
• Device Sequence Number: 9649006
• Product Code: FGE
• UDI-Device Identifier: 00827002217072
• UDI-Public: (01)00827002217072(17)280529(10)C2304468
• 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): 11/07/2025

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: C2304468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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