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

Catalog Number	FS-OA-10
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2017
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 1 x fs-oa-10 of lot c1212216 was returned to cirl for a lab evaluation.During the lab evaluation the stylet was protruding approximately 1ml distal of the radiopaque band.A tear was visible in the tubing which began 5ml from the distal tip; this was found to be consistent with the stylet placement.There was damage to the ide port consistent with short wire use and the full length support stylet would also be consistent with this.It was noted that the stent would not have left the manufacturing facility in a damaged state.The customer complaint was confirmed on visual inspection as the returned device was found to be damaged- the stylet was protruding at the tip.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 may be noted that according to the instructions for use, the user is 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¿.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Prior to distribution, all fs-oa-10 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Capa was raised in relation to the complaint issue & will deal with any actions identified.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This initial mdr is being submitted based on the device malfunction reporting precedence for this device family for the issue of 'stylet wire/sheath perforation'.As per cc form: the doctor noticed a metal wire coming out of the tip of the oasis.Took a new oasis to finish the procedure.Metal wire came out of the tip.Behind the radio the wire comes out.

• Brand Name: FUSION 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: 6676246
• Report Number: 3001845648-2017-00238
• Device Sequence Number: 13464273
• Product Code: FGE
• UDI-Device Identifier: 00827002315273
• UDI-Public: (01)00827002315273(17)190316(10)C1212216
• Combination Product (Y/N): N
• Initial Reporter Country: NE
• PMA/510(K) Number: K040151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

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: FS-OA-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1