MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number	ZILBS-635-10-8
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	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Zilbs-635-10-8 was scheduled to be implanted in the common bile duct with the proximal end of the stent slightly protruding into the duodenum.Via endoscope.After est (endoscopic papillotomy), the physician advanced the delivery system over a pre-positioned wire guide (olympus/visiglide 25).The physician began deployment with the plan to place the proximal end of the stent slightly out into the duodenum, but halfway through the deployment, he was unable to pull the sheath.The physician removed the delivery system and placed another device of same rpn (c2123810).File related to (b)(4) ¿ malfunction of deployment.This file captures the user error of the wrong size wireguide with the replacement device.Patient outcome: no health hazard.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k163018.This file was opened to capture the user error of the use of a smaller than required wire guide size used with the replacement device.This file is related to (b)(4).Device evaluation: the device evaluation could not be completed as the zilbs-635-10-8 device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for lot number c2123810 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: there is evidence to suggest that the customer did not follow the label.The information in the file states that a 0.025" wire guide was used in the replacement device.The japanese packaging insert, c-es1207m06 rev006, for this device states ¿equipment required, 0.89 mm (0.035 inch) wire guide¿.Image review: an image was not returned for evaluation.Root cause analysis: investigation findings conclude a definitive root cause of user error can be attributed to the use of an incorrect size wireguide with the device.The complaint information states that a 0.025" wire guide was used, the japanese packaging insert for this device states that a 0.89 mm (0.035 inch) wireguide is to be used with this device.User /use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and /or labelling requirement.The user has not complied with the requirements of the ifu and /label.Trending will monitor if any further investigation is required.Confirmation of complaint: 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 of investigation: this file was opened to capture the user error of the use of a smaller than required wire guide size used with the replacement device.Confirmed quantity of 01 device used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude a definitive root cause of user error can be attributed to the use of an incorrect size wireguide with the device.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 04-oct-2024.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 20244648
• Report Number: 3001845648-2024-00564
• Device Sequence Number: 12603942
• Product Code: FGE
• UDI-Device Identifier: 10827002506241
• UDI-Public: (01)10827002506241(17)261213(10)C2123810
• Combination Product (Y/N): N
• 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): 10/04/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: ZILBS-635-10-8
• Device Lot Number: C2123810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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