MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G23130
Medical Device Problem Code	Delivery System Failure (2905)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 customer reported the following complaint issue: ¿after wire guide placement and sphincterotomy they wanted to place an evo-b.They heard a noise into the handle with the impossibility to deploy the stent.They put a new one with success.¿ 1 x evo-10-11-10-b was returned to cirl for evaluation.Upon evaluation of the returned device it was noted that the lockwire was in place on return.The red shuttle deployment marker was at the front of the handle.The stent was partially deployed on return.There was a kink evident in the flexor at the handle, this could have occurred on transport back.The directional button was in the neutral position on return.Deployment and retraction were possible with a little resistance felt.The stent was fully deployed during lab evaluation.The device functioned okay, however there was stiff resistance felt using it.The device was dismantled during lab evaluation to show that all internal components were fine.There was also a prominent kink noted more distal on the flexor which possibly could have been caused on insertion into the scope.The customer complaint was confirmed as the flexor was kinked.As usage conditions cannot be replicated in the laboratory setting, a definitive root cause for this complaint could not be conclusively determined.However, it is possible that the flexor became kinked on insertion into the scope which could have caused the issues experienced in deploying the stent.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution all evo-10-11-10-b devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, notes section the user is instructed of the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use".A review of the manufacturing records for evo-10-11-10-b did not reveal any discrepancies that could have contributed to this issue.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
After wire guide placement and sphincterotomy they wanted to place an evo-b.They hard a noise into the handle with the impossibility to deploy the stent.They put in a new one with success.Update of the description: they started to deployed the stent when they heard the noise in the handle.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6879215
• Report Number: 3001845648-2017-00404
• Device Sequence Number: 18996825
• Product Code: FGE
• UDI-Device Identifier: 10827002231303
• UDI-Public: (01)10827002231303(17)190624(10)C1371175
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121430
• 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): 08/23/2017

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 Model Number: G23130
• Device Catalogue Number: EVO-10-11-10-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1