MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G26849
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
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 the investigation conclusions.
Event or Problem Description
It was unable to release the stent in the bile duct, so the user replaced it with other manufacturer's device to complete the procedure.Reporting due to the precedence for "difficult to advance".
Event or Problem Description
It was unable to release the stent in the bile duct, so the user replaced it with other manufacturer's device to complete the procedure.Reporting due to the precedence for "difficult to advance".
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).Problem statement: ¿the customer reported the following complaint issue: ¿it was unable to release the stent in the bile duct, so the user replaced it with other manufacturer's device to complete the procedure.The patient did not experience any adverse effects due to this occurrence¿.Lab evaluation: 1 x oats-8.5-9 device was returned to cirl for a lab evaluation.A lab evaluation was held on 12th april 2018.On evaluation of the returned device, the device functioned as intended.No defects were observed.The device appeared unused even though there were some minor marks noted near the centre of the stent.Additional information was requested from the customer to determine if the correct device was returned and to clarify the difficulty with releasing the stent in the bile duct.However, feedback from the originator indicated that this information may not be available.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.It was clarified that the device returned has no defect and not a reject.Complaint is not confirmed as the failure could not be verified in the laboratory.Document review: a review of the manufacturing records for the oats-8.5-9 device of lot # did not reveal any discrepancy related to the complaint issue.Fqc/ pkg/iqc rewiew: prior to distribution, all oats devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Ifu review it may be noted that according to instructions for use, the user is given the following instructions: ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.Summary: complaint is not confirmed as the failure could not be verified in the laboratory.

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7377563
• Report Number: 3001845648-2018-00147
• Device Sequence Number: 16514644
• Product Code: FGE
• UDI-Device Identifier: 00827002268494
• UDI-Public: (01)00827002268494(17)200720(10)C1380986
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: G26849
• Device Catalogue Number: OATS-8.5-9
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1