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

Model Number	G21426
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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After placing a guidewire (boston scientific/endoselector 0.025 inch) in the pancreatic duct, when advancing a stent over the guidewire, the guidewire did not exit the guidewire lumen of the stent but instead exited the gutter, making it unusable.The procedure continued using a different model gepd (detail unknown).The procedure was completed without issue.No health hazard.1.Does the complaint relate to: device placement/device removal/observation prior to patient contact during advancing over a wire guide.2 what was the target location for the stent? the pancreatic duct.3 please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.4 what is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure? boston scientific/endoselector 0.025inch.5 was the wire guide lubricated prior to use? yes.6 was the device at the centre of the complaint inspected for damage prior to use? yes.7 was the wire guide inspected for damage prior to use? yes.8 were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? unknown.10 did the patient involved exhibit altered anatomy or tortuous anatomy? no.11 if not with the device in question, how was the procedure finished? the procedure completed with a different model gepd (detail unkonwn).12 did the patient require any additional procedures as a result of this event? no.15 were any other defects observed on the device prior to return (other than the reported complaint issue)? no.16 was a straightener used to straighten the stent? no.17 (if any damages were confirmed prior to use)was the package damaged? no.For complaints occurring during use (once in contact with endoscope) also ask: 1 what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? olympus/jf260v.2 does your medical facility have a service/maintenance schedule associated with its endoscopes? yes.3 was resistance encountered when advancing the wire guide to the target location? unknown.4 were any modifications made to the complaint device or accessories used with the device in this procedure? ¿ for example guiding catheter shortened.No.5 please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.No.6 did the patient require any additional procedures as a result of this event? no.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 24-oct-2025.
Additional Manufacturer Narrative
Device evaluation: 1 unit of zepdf-7-4 of lot number c2181798 device was returned for evaluation opened not in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 10 sep 2025.On evaluation of the devices the following observations were made: visual inspection: stent and catheter returned.Stent examined and kinks observed on the 02nd and 04th side port of the pigtail curl.Slight hole/rupture observed on the 04th side port of the pigtail curl.Functional inspection: 0.035 inch wire guide does not pass through the stent the reported failure was observed.Manufacturing records review: prior to distribution 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: the japanese packaging insert c-es0202 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.This states the following: ¿remove this product from the package and inspect with particular attention to bends, kinks and breaks¿.As per the instructions for use¿s notes section (ifu0055), 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 (ifu0055), 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 that the customer did not follow the 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.As the wire guide has a smaller diameter which might have caused misalignment and led to an increased friction.This misalignment allowed the wire to exit through the stent gutter rather than the lumen, rendering the stent unusable.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 visual/functional inspection.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.As the wire guide has a smaller diameter which might have caused misalignment and led to an increased friction.This misalignment allowed the wire to exit through the stent gutter rather than the lumen, rendering the stent unusable.According to the information provided, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZIMMON PANCREATIC STENT SET
• 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: 23004331
• Report Number: 3001845648-2025-00462
• Device Sequence Number: 8997006
• Product Code: FGE
• UDI-Device Identifier: 00827002214262
• UDI-Public: (01)00827002214262(17)270610(10)C2181798
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K900923
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: G21426
• Device Catalogue Number: ZEPDF-7-4
• Device Lot Number: C2181798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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