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

Catalog Number	ZILBS-635-6-8
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 zilbs-635-6-8 device of lot number c1140348 involved in this complaint was returned for evaluation with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was carried out.Additional information requested from customer.Investigation will be updated once information has been received.The following additional information has been received from the sales representative.Dilation and a sphincterotomy had been performed before the occurrence.Resistance was encountered when advancing the delivery system through the target location.The complaint device was not advanced through a previously placed stent.The delivery system was advanced through a fujifilm endoscope, over a hydrophilic, cook acrobat wire guide of 0.035¿ diameter.The stent was not deployed, and another device was used instead.The patient was being treated for a hilar cholangiocarcinoma.On evaluation of the returned device, it was noted that the flexor had detached from the handle at the white connector cap.It was also observed that the flexor had separated, and uncoiled, 51cm distally from the handle.The customer complaint is confirmed as the outer flexor was found to be separated.Based on the information provided, the event occurred during deployment, and possible causes for this occurrence could include high deployment forces.Possible causes for these high forces could include a difficult patient anatomy.From customer testimony; it is known that the device encountered resistance during advancement, which is also possibly due to tortuous anatomy.This difficult anatomy and high forces could have overcome the strength of the flexor, causing the separation observed.However, as the conditions of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.Prior to distribution, all zilbs (zilver biliary) devices are subject to visual inspection and functional checks to ensure device integrity.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 this lot number.According to the initial reporter, the patient did not experience any adverse effects, and did not require any additional procedures due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
During ercp, the user advanced two stents along wire guide under endoscope through left and right hepatic duct.A -represent sent through left hepatic duct.B- -represent sent through right hepatic duct.The user advanced b into desired position successfully and tried to deploy two stents at the same time.Then they found that the b stent could not deploy because the handle portion was detached.Withdraw the stent immediately.After withdrawing, about 55 cm distal from the end of handle of outer sheath was peeling.The peeled portion sheath was operated outside, so no section was left inside patient body.

• 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
• MDR Report Key: 6307215
• Report Number: 3001845648-2017-00040
• Device Sequence Number: 443253
• Product Code: FGE
• UDI-Device Identifier: 10827002506227
• UDI-Public: (01)10827002506227(17)180820(10)C1140348
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K020788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2017

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: ZILBS-635-6-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 50