MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48028

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k163468.(b)(4).Investigation is still progress, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿tip separation'.User found out the white component fell off from top of sheath while advancing 10cm of wire guide.User changed another same device to finish the procedure.

Event Description

Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿tip separation'.User found out the white component fell off from top of sheath while advancing 10cm of wire guide.See picture user changed another same device to finish the procedure.

Manufacturer Narrative

510(k) number: k163468.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 device involved in the complaint was evaluated in the laboratory on 2th march 2019.Multiple defects were observed.Joint between polyimide and peek tubing failed, joint between polyimide and white tip failed and yellow marker and radiopaque markers separated.All the defects are related.Upon evaluation of the returned device, polyimide tube and white tip wasn't returned with the device therefore following the lab evaluation, the following queries were sent to the originator to aid with the investigation.Where is the white tip and polyimide tube? please see attached picture.Did the device got caught up on something? no.Was any additional force applied? no.Prior to distribution all evo-25-30-8-c 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.A review of the manufacturing records for evo-25-30-8-c device of lot number c1437926 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1437926; upon review of complaints this failure mode has not occurred previously with this lot #c1437926.The instructions for use ifu0052-10 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is no evidence to suggest that the customer did not follow the instructions for use ifu0052-10.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to excessive force applied to the device distally causing the separation of polyimide tubing from the device resulting in the joint failure between polyimide and peek tubing.This also caused the polyimide and white tip joint failure and yellow marker and radiopaque markers separation.Polyimide tube and white tip wasn't returned with the device therefore a definitive root cause could not be determined.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

510(k) number: k163468.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 progress, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿tip separation.' user found out the white component fell off from top of sheath while advancing 10cm of wire guide.See picture; user changed another same device to finish the procedure.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8482015
• MDR Text Key: 140963583
• Report Number: 3001845648-2019-00132
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)200103(10)C1437926
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1437926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1