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

Model Number	G50620
Medical Device Problem Code	Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
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 investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.
Event or Problem Description
Initial mdr is being submitted based on the device malfunction precedence: ¿flexor breaking during deployment (incl.Flexor/handle separation)¿.To place a metallic stent in the malignant stricture of hepatic portal region, the user advanced the delivery system but it would not pass through the stenosed lesion.So he dilated the stenosed lesion using an epbd balloon catheter and a dilator and tried again, but the delivery system would not pass through the stenosed lesion.After several attempt, only the outer sheath advanced forward as covering the inner catheter tip, so he removed and replaced it with another zilver 635 biliary self expanding metal stent to complete the procedure.The user commented that the stenosis was severe, but he has never experienced this phenomenon before.
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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This follow up mdr is being submitted to cancel the initial mdr.A conservative approach was taken in initially assessing this complaint.The customer confirmed that the flexor did not separate from the handle and the confirmed failure mode is "advancement difficulty".No reporting malfunction precedence exists for this complaint event for this product family.No adverse effects to the patient was reported as occurring.H3 other text : 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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This follow up mdr is being submitted to cancel the initial mdr.A conservative approach was taken in initially assessing this complaint.The customer confirmed that the flexor did not separate from the handle and the confirmed failure mode is "advancement difficulty".No reporting malfunction precedence exists for this complaint event for this product family.No adverse effects to the patient was reported as occurring.
Event or Problem Description
This follow up report is being submitted to cancel the initial mdr report.The file has been re-assessed based on additional information.Initial mdr submitted based on the device malfunction precedence: ¿flexor breaking during deployment (incl.Flexor/handle separation)¿.To place a metallic stent in the malignant stricture of hepatic portal region, the user advanced the delivery system but it would not pass through the stenosed lesion.So he dilated the stenosed lesion using an epbd balloon catheter and a dilator and tried again, but the delivery system would not pass through the stenosed lesion.After several attempt, only the outer sheath advanced forward as covering the inner catheter tip, so he removed and replaced it with another zilver 635 biliary self expanding metal stent to complete the procedure.The user commented that the stenosis was severe, but he has never experienced this phenomenon before.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7322978
• Report Number: 3001845648-2018-00117
• Device Sequence Number: 16173062
• Product Code: FGE
• UDI-Device Identifier: 10827002506203
• UDI-Public: (01)10827002506203(17)201108(10)C1417870
• Combination Product (Y/N): N
• PMA/510(K) Number: K020788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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 Model Number: G50620
• Device Catalogue Number: ZILBS-635-8-6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1