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

Model Number	G22167
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	07/25/2025
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
Per rep - before use, they went to put the wire through the stent and could not get it to go through.They had used the straightener.They then noticed a kink in the stent.It was an.035 wire but the other details of the wire have not been confirmed.The procedure was successfully completed with another device of the same type.Does the complaint relate to: -observation prior to patient contact.· device placement, · device removal, · observation prior to patient contact.If not, with the device in question, how was the procedure finished? -with another device of the same type what was the target location for the stent? -bile duct please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.-cool dark room *what is the reorder number, diameter and length of the wire guide that was used with this device in this procedure? -.035, otherwise, unknown.Was the wire guide lubricated prior to use? n/a, yes, no -wetted with water.*was the wire guide inspected for damage prior to use? n/a, yes, no* -yes.Was the device at the center of the complaint inspected for damage prior to use? n/a, yes, no -yes.Were previous procedures i.E., sphincterotomy etc.Carried out prior to placing the complaint device? n/a, yes, no (if yes, please indicate the procedure performed.) -n/a.Did the patient involved exhibit altered anatomy or tortuous anatomy? n/a, yes, no -n/a.*if not with the device in question, how was the procedure finished? -with another device of the same type.What intervention (if any) was required? -none.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 7 oct 2025.
Additional Manufacturer Narrative
Device evaluation: the device zso-7-7 of c2289888 lot number was returned not in its original packaging.On evaluation of the device the following observations were made: visual inspection: stent returned with pigtail straightener in the incorrect orientation.Stent examined, kinks observed on the 3rd and 5th portholes of the tapered end pigtail curl.Functional inspection: 0.035 inch wire guide does not pass the kinks.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-7-7 of c2289888 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: 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 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 from the available information.Based on the information provided a possible root cause could be attributed to the kink occurring while the stent was being straightened as it was being loaded onto the wire-guide likely causing issue reported.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 visual/functional inspection.There was no impact to the patient as this observation was made prior to patient contact.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 the stent was being straightened as it was being loaded onto the wire-guide likely causing issue reported.

• 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: 22861955
• Report Number: 3001845648-2025-00415
• Device Sequence Number: 13096235
• Product Code: FGE
• UDI-Device Identifier: 00827002221673
• UDI-Public: (01)00827002221673(17)280417(10)C2289888
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Study,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: G22167
• Device Catalogue Number: ZSO-7-7
• Device Lot Number: C2289888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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