MAUDE Adverse Event Report: COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G21469
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
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.Additional information 23rd nov 2017; ¿the stent itself was placed in the patient.I don't think it will return.They don't use the flap protector in this hospital.¿ upon further investigation, it has been determined that the complaint stent was sent to cook endoscopy.A request has been made on 27th nov 2017 for this device to be returned to cirl for evaluation.An additional, complaint has been opened by cook endoscopy to deal with the wire lock addressed in this complaint.This investigation will only look at pr198985.Lab evaluation: this device was not returned to cirl for a lab evaluation.Therefore a document based evaluation has been performed.Root cause: a possible root cause for this complaint is that the stent could not be passed through the wire lock because the physician did not use the flap protector.This is a user error situation.Ifu review: it may be noted that according to the instructions for use, ifu0045-6, 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¿.As per step 2; ¿load positioning sleeve onto duodenal flap end of stent.¿ fqc/ prd review: prior to distribution, all biliary devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl as per fqc0128.Document review: a review of the manufacturing records for the biliary device of lot c1304731 did not reveal any discrepancy related to the complaint issue.Summary: this complaint is confirmed based on customer testimony.However, it may be noted that this is a user error situation.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Stent did not go through the wire lock.Wire lock and stent only to be returned."as per complaint form": the stent could not be pushed through the valve of the wire lock.It worked with an 8.5 french stent though.

• Brand Name: COTTON-LEUNG BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7126837
• Report Number: 3001845648-2017-00601
• Device Sequence Number: 1210658
• Product Code: FGE
• UDI-Device Identifier: 00827002214699
• UDI-Public: (01)00827002214699(17)191209(10)C1304731
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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: G21469
• Device Catalogue Number: CLSO-10-7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1