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

Catalog Number	ZILBS-635-10-10
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k163018 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Description of event: as per source doc: please log a complaint and send me a returns label for a lot c2085665 ref zilbs-635-10-10 royal oldham hospital, it could not be deployed.Patient outcome: requested.
Additional Manufacturer Narrative
Pma/510(k) # k163018 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 clinical input received on 29-jul-2024, the device is used in an unintended or unsafe manner.Wires placed and delivery systems for bilateral stents and stent would not unsheath so another was used to complete the procedure as per source doc: please log a complaint and send me a returns label for a lot c2085665 ref zilbs-635-10-10 (b)(6) hospital, it could not be deployed.A section of the device did remain inside the patient¿s body.Staff retrieved it by removing & pulling hard.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.
Additional Manufacturer Narrative
Pma/510(k)#: k163018.This file was opened in response to a report from royal oldham hospital, stating ¿it could not be deployed¿.Device evaluation: the device evaluation could not be completed as the 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 c2085665 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label: there is evidence to suggest that the customer did not follow the label.The device ifu0065 states that equipment required includes a ¿.035inch wire guide of appropriate length¿.The complaint information states that a 0.025-inch wireguide was used.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 a non-recommended wire guide with the device.The complaint information states that a 0.025-inch wireguide was used.The device ifu states that equipment required includes a ¿.035inch wire guide of appropriate length¿.It is possible that the user error of a smaller that recommended wireguide could have provided insufficient support for the device and contributed to the difficulty with deployment of the stent.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 in response to a report from royal oldham hospital, stating ¿it could not be deployed¿.Confirmed quantity of 01 device used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A definitive root cause of user error was determined.An incorrect sized wireguide was used.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 12-sep-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: 19572980
• Report Number: 3001845648-2024-00281
• Device Sequence Number: 11754713
• Product Code: FGE
• UDI-Device Identifier: 10827002238159
• UDI-Public: (01)10827002238159(17)260829(10)C2085665
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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: 08/29/2026
• Device Catalogue Number: ZILBS-635-10-10
• Device Lot Number: C2085665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 05/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/26/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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