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

Catalog Number CLSO-8.5-12

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The doctor wanted to insert clso-8.5-12 for left hepatic duct.They loaded the clso-8.5-12 at the oa-8.5, nad put through the located awg2-35-450 in left hepatic duct.After the inner sheath of oa-8.5 passed through the stricture site, they released the rock of oa-8.5 and pulled to separate the inner sheath.However, the inner sheet was not pulled well.The nurse felt severe resistance.The out sheath (pusher) of oa-8.5 was also not pushed well.She pulled very hard to place the clso-8.5-12 and remove the oa-8.5.The inner sheet of oa-8.5 was stretched long and thin.This complaint was created to capture the difficult advancement of the clso-8.5-12.Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? no.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation: 1 x clso-8.5-12 of unknown lot number was not returned to cirl for evaluation.Document review including ifu: prior to distribution all clso-8.5-12 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 the clso-8.5-12 device could not be completed as the lot number is unknown.It should be noted that according to the instructions for use, ifu0045-7, the following is stated in the notes section, ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working conditions, do not use.¿.There is no evidence to suggest that the use did not follow the instructions for use.Complaint closure due date and investigation due date were calculated as per cirl root cause review: a definitive root cause could not be determined as the device was not returned for evaluation.A possible root cause could be attributed to user technique where excessive force was applied to place the stent and overcome the resistance that was encountered.Summary: complaint is based on customer testimony.According to the information reported, 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.

• Brand Name: COTTON-LEUNG BILIARY STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: aisling hassett ; holstein campus kiel; arnold- keller str- 3; limerick ; 061334440
• MDR Report Key: 13076457
• MDR Text Key: 290796982
• Report Number: 3001845648-2021-00896
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: CLSO-8.5-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1