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

Catalog Number	ZIB6-40-10.0-80
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k163169.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.The zib6-40-10.0-80 device of lot c1133021 related to this complaint was returned with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.On evaluation of the returned device, there was no tactile damage observed.A minor kink was noted in the inner catheter (peek), which could have occurred during transport.The engineers completed the stent deployment in the lab, with no resistance encountered.The outer catheter (flexor) was separated from the handle at the white connector cap.The customer complaint is confirmed as the outer sheath was pulled from the handle.Possible causes for this occurrence could include patient anatomy.A difficult anatomy could have caused the resistance encountered during deployment.This resistance could have led to high deployment forces, which could have caused or contributed to the flexor separating from the handle.However, as the circumstances of use cannot be replicated in the laboratory environment, a definitive root cause cannot be determined.Prior to distribution, all zib6 (zilver biliary) devices are subject to visual inspection and functional checks to ensure device integrity.This includes a 100% check of the connection at the white connector cap.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information provided to date, there is no evidence to suggest any manufacturing issues associated with lot number c1133021.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another device was used to complete the procedure.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
The outer sheath got separated from the handle during use, so the stent could not be placed.Then, another manufacturer's device was used instead.

• Brand Name: ZILVER 635 SELF-EXPANDING BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6460347
• Report Number: 3001845648-2017-00115
• Device Sequence Number: 476685
• Product Code: FGE
• UDI-Device Identifier: 10827002360133
• UDI-Public: (01)10827002360133(17)180730(10)C1133021
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

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 Catalogue Number: ZIB6-40-10.0-80
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1