MAUDE Adverse Event Report: COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G21685
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
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.Investigation is still pending, a follow up mdr will be submitted to include investigation conclusions.
Event or Problem Description
This file is being submitted based on the fda mdr precedence for this device family for the issue of ¿difficult advancement'.They tried to put the clso-7-9 in to the bile duct, but the clso-7-9 could not pass through the stricture in the bile duct.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).1 x clso-7-9 device of lot # c1274933 was returned to cirl for evaluation.Upon evaluation of the returned device there were no anomalies noted that could have contributed to the complaint issue.There were slight pinch marks consistent with the removal of the stent via forceps.The complaint is confirmed based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.A possible root cause could relate to the patient anatomy and a tight stricture.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.Document review: a review of manufacturing records for lot # c1274933 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue effects the entire lot c1274933, a review of the complaints history determined that this failure has not occurred previously with lot c1274933.Prd/fqc/pkg review : prior to distribution all clso-7-9 devices are subject to 100% inspection to ensure device integrity; these inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: it may be noted that according to the instructions for use, ifu0045-6, a contraindications identified includes an ¿inability to pass wireguide or stent through obstructed area¿ and the user is also instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However, it is possible that a tight stricture may have contributed to the failure of the stent to pass the stricture and a smaller or firmer stent may have been more appropriate for the stricture.Summary: the complaint is confirmed based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This file is being submitted based on the fda mdr precedence for this device family for the issue of ¿difficult advancement'.They tried to put the clso-7-9 in to the bile duct, but the clso-7-9 could not pass through the stricture in the bile duct.

• Brand Name: COTTON-LEUNG BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7955322
• Report Number: 3001845648-2018-00478
• Device Sequence Number: 1387248
• Product Code: FGE
• UDI-Device Identifier: 00827002216853
• UDI-Public: (01)00827002216853(17)190920(10)C1274933
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 09/20/2019
• Device Model Number: G21685
• Device Catalogue Number: CLSO-7-9
• Device Lot Number: C1274933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1