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

Model Number	G21807
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
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.Device evaluation: 1 x clso-10-10 of lot number c1517082 was returned to cirl for evaluation.It was in a used state and it was returned in its original open packaging.Lab evaluation: 1 x clso-10-10 of lot number c1517082 was returned to cirl for evaluation on 1st february 2019.In summary the following observations were made during lab evaluation.No visual defect was observed.A 0.035 inch wireguide was passed through the stent without issue.Complaint is confirmed as based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.Documents review including ifu review: a review of the manufacturing records for the device of lot # c1517082 did not reveal any discrepancy related to the complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is evidence or no evidence to suggest that there are any manufacturing issues associated with lot number c1517082.Prior to distribution all clso-10-10 devices are subjected to visual and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in cirl.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.There is also a 100% visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.The instructions for use, ifu0045-6 which accompanies this device instructs the user ¿if any abnormality is detected that would prohibit proper working condition, do not use¿.Root cause review: a definite root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory.A possible contributing factor to the issue encountered may be due to user error.It should be noted that that a 0.025¿ wireguide was used however a 0.035¿ wireguide is recommended as per the product label, it is possible that this negatively affected the ability to pass the stricture as a 0.025¿ wireguide would not offer as much support as a larger 0.035¿ wireguide.Summary: complaint is confirmed as based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.As per information provided, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
They tried to put the stent in the bile duct, but the stent could not pass through the stricture in the bile duct.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.

• 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: 8314880
• Report Number: 3001845648-2019-00041
• Device Sequence Number: 11009546
• Product Code: FGE
• UDI-Device Identifier: 00827002218079
• UDI-Public: (01)00827002218079(17)210706(10)C1517082
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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 Expiration Date: 07/06/2021
• Device Model Number: G21807
• Device Catalogue Number: CLSO-10-10
• Device Lot Number: C1517082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR