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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k040505 / 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.Problem statement: "percutaneous metallic stent placement in bile duct by approach from abdominal region was performed.After the delivery system of the complaint zib6-40-10.0-80 reached the target lesion, deployment of the stent was begun.However, during the withdrawal of the handle, the outer sheath got separated from the handle.The system was retrieved out of the body, another device was used instead and the procedure was completed successfully." device evaluation: the zib6-40-10.0-80 device 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 conducted.From customer testimony, it is known that the patient¿s anatomy was not calcified or tortuous.The device related to this occurrence underwent a laboratory evaluation on the 28th june 2018.On evaluation of the returned device, it was found that the flexor was separated from the handle at the white connector cap.The device was returned with the stent still loaded in the flexor.The stent was released in the lab, and was measured as 8cm long.The stent was undamaged.The flexor length was 40.6cm, which is within specification 40cm +1.3cm -0.8cm.Complaint is confirmed as the failure was verified in the laboratory.The flexor was found to be separated from the handle at the white connector cap.Possible causes for this occurrence could include insufficient strength of the flexor to white connector cap joint.As the physician attempted to deploy the device, it is possible that the device encountered resistance.This resistance could have caused or contributed to the flexor separating from the handle.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the product packaging insert.It may be noted that project ime-0035-bms has been initiated to prevent the reoccurrence of handle/flexor separation.Document review: prior to distribution all zilver biliary 635 devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.Summary: complaint is confirmed as the failure was verified in the laboratory.The flexor was found to be separated from the handle at the white connector cap.The risk was determined to be low (category iia).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Initial mdr is being submitted based on the device malfunction precedence: ¿flexor breaking during deployment (incl.Flexor/handle separation)¿.Percutaneous metallic stent placement in bile duct by approach from abdominal region was performed.After the delivery system of the complaint zib6-40-10.0-80 reached the target lesion, deployment of the stent was begun.However, during the withdrawal of the handle, the outer sheath got separated from the handle.The system was retrieved out of the body, another device was used instead and the procedure was completed successfully.

• 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: 7672926
• Report Number: 3001845648-2018-00312
• Device Sequence Number: 13614455
• Product Code: FGE
• UDI-Device Identifier: 10827002360133
• UDI-Public: (01)10827002360133(17)210323(10)C1465990
• 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): 06/12/2018

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: 03/23/2021
• Device Catalogue Number: ZIB6-40-10.0-80
• Device Lot Number: C1465990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1