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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
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 the customer reported the following issue: ¿the catheter couldn't be released so stent couldn't be exposed fully as per complaint form: the catheter couldn't be released so stent couldn't be exposed fully.The catheter system and the stent were then completely removed from the patient and from the scope.¿ the following additional information was received: ¿yes, the stent was partially deployed, when removed from the patient body.¿ 1 x evo-10-11-10-b was returned to cirl for evaluation.Upon evaluation of the device it was noted that lockwire anchor assembly was not returned.The stent was fully deployed on return.The stent carrier to retrieval loop shaft joint was broken.The cannula had separated from the band and loop.The retrieval loop cannula had pierced out through the side of the flexor.Some of the lockwire was still present which would have come out of the retrieval loop indicating that the damage had occurred prior to releasing the lockwire.All components of the delivery system have been accounted for except the part of the lockwire and anchor assembly which were not returned.The customer complaint was confirmed as the stent carrier to retrieval loop shaft joint was broken.As usage conditions cannot be replicated within the laboratory setting, a definitive root cause could not be conclusively determined.It is thought that the failure of the joint between the stent carrier and the retrieval loop shaft assembly (which the retrieval loop shaft and the retrieval loop joint is part of) is unlikely to be the result of a manufacturing defect as this joint is proof loaded to 15n using tool ipe0711 during the introducer manufacture in cook ireland.The retrieval loop shaft and the retrieval loop pusher is also proof loaded to 40n by the retrieval loop assembly supplier during its assembly which was noted during lab evaluation.Additional information was received which was discussed with engineering: ¿how was the stent released/removed from the system? when was the lock wire pulled? he pulled out the scope and introducing system with the stent came out too.He tried to remove the introducing system and the stent.So all were outside of the patient.The lock wire was stuck a bit at the elevator, he removed the lock wire from the elevator (outside of the patient) and pulled it out when did the damage to the device occur, inside the patient or after removal from the patient? do you mean with device the stent and introducing system? he don¿t know where it¿s damaged but he thinks inside of the patient because the device was not working well¿ from this information it would indicate that the elevator may have been the cause of the problems experienced removing the lockwire 'the lock wire was stuck a bit at the elevator' which may have lead to the damage that was caused to the device.Prior to distribution all evo-10-11-10-b devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.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
The catheter couldn't be released so stent couldn't be exposed fully as per complaint form: the catheter couldn't be released so stent couldn't be exposed fully.The catheter system and the stent were then completely removed from the patient and from the scope.

• 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: 6705085
• Report Number: 3001845648-2017-00265
• Device Sequence Number: 1570416
• Product Code: FGE
• UDI-Device Identifier: 10827002231303
• UDI-Public: (01)10827002231303(17)190302(10)C1332288
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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: 07/12/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1