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

Model Number	G21708
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	08/28/2025
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-7-12 into the cbd through the prepositioned (visiglide 2 0.025 straight) wire guide, assistant nurse tried to straighten the zso-7-12 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-7-12 was used.And wire guide was not changed.
Additional Manufacturer Narrative
Device evaluation: the device evaluation of zso-7-12 of c2304385 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 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: instructions for use (ifu0045), which accompanies this device, instructs the user: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The precautions section of the instructions for use also states: " care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking of the stent." as per the precautions section of the instructions for use (ifu0045), "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".There is evidence to suggest that the customer did not follow the instructions for use.(ifu0045).It is known that a 0.025 inch wire guide was used with the device.The product label states the guide wire size for use with this device is 0.035".There is evidence to suggest that the customer did not follow the instructions for use.However, based on the available information, it appears that the stent was already bent before it was loaded onto the wire guide.Additionally, there is evidence from the additional information that the 0.025-inch wire guide was used the replacement device 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 it was being straightened, as it was being loaded onto the wire guide.There have been several attempts made to obtain additional information 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: confirmed quantity of 1 device, confirmed prior to use.The complaint is confirmed based on customer/or rep testimony.According to the initial reporter, no health consequences or impacts were reported as it occurred prior to use.Complaints of this nature will continue to be monitored for similar events.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 it was being straightened, as it was being loaded onto the wire guide.There have been several attempts made to obtain additional information.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2025.Answered on (b)(6) 2025.1.Was the kink observed on the stent prior to loading it onto the 0.025¿ wireguide or after? no kink was observed on the stent prior to loading.However, when the stent could not be loaded onto the wire guide, we checked and found that it had become kinked.

• 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: 23080929
• Report Number: 3001845648-2025-00475
• Device Sequence Number: 9719609
• Product Code: FGE
• UDI-Device Identifier: 00827002217089
• UDI-Public: (01)00827002217089(17)280529(10)C2304385
• 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): 10/23/2025

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: G21708
• Device Catalogue Number: ZSO-7-12
• Device Lot Number: C2304385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/17/2025
• 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