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

Model Number	G21393
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	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to patient contact.The gutter section was damaged when the pig section was stretched using a straightener.Another device of same rpn was used.Prior to patient contact and no health hazard.
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 10 dec 2025.
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 zebd-7-4 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zebd-7-4 device of lot number: c2313080 did not reveal any discrepancies that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.Review historical data: a review of the manufacturing records for the zebd-7-4 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: c2313080.Instructions for use and label: the notes section of the instructions for use (ifu0045), 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".There is no evidence to suggest that the customer did not follow the instructions for use.(ifu0045).It should be noted that in the japanese packaging insert (c-es0202m18) states: "remove this product from the package and inspect with particular attention to bends, kinks and breaks".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 may be attributed to the stent becoming kinked during the straightening process as the pigtail curl was being unfolded and straightened with the pigtail straightener resulting in subsequent kinks forming.Information in the patient/event notes confirmed that the "gutter section" mentioned in the description of event was a reference to the exact location on the pigtail curl where the kink occurred which would align with the damage occurring during the straightening process.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 customer, the stent was damaged.Confirmed quantity of 1 device, confirmed prior to use.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 may be attributed to the stent becoming kinked during the straightening process as the pigtail curl was being unfolded and straightened with the pigtail straightener resulting in subsequent kinks forming.Information in the patient/event notes confirmed that the "gutter section" mentioned in the description of event was a reference to the exact location on the pigtail curl where the kink occurred which would align with the damage occurring during the straightening process.

• Brand Name: ZIMMON BILIARY 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: 23401789
• Report Number: 3001845648-2025-00547
• Device Sequence Number: 15939050
• Product Code: FGE
• UDI-Device Identifier: 00827002213937
• UDI-Public: (01)00827002213937(17)280623(10)C2313080
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 12/10/2025

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: G21393
• Device Catalogue Number: ZEBD-7-4
• Device Lot Number: C2313080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/03/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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