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

Catalog Number CLSO-10-12

Device Problem Difficult to Advance (2920)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Upon putting through oa-10 through the guide wire, end user noticed that there is a kink/damage on the purple catheter on the device.(b)(4) the stent (clso) was not deployed (b)(4).Via this oa-10 hence it was taken out, replaced by sis-10 with a pre-loaded clso (plastic stent) and it also kinked upon deploying the stent.(b)(4).The case was then postponed as it was unsuccessful.This file will capture difficult advancement of clso-10-12 did any piece of the device remain inside the patient¿s body? no.Did the patient require any additional procedures due to this occurrence? no.Did the complainant inform of any adverse effect(s) on the patient due to this occurrence? no.Did the complainant inform that the product caused or contributed to the adverse effect(s)? no.

Manufacturer Narrative

Device evaluation: 1 x clso-10-12 of unknown lot number was not returned to cirl for evaluation.This file is capturing the difficult advancement of the clso-10-12.This file is related to two complaints.One complaint captures the kink/damage on the purple catheter (oa-10) second complaint captures the kink/damage on the catheter (sis-10) document review including ifu review: prior to distribution all clso-10-12 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-10-12 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.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.A further possible cause is that the kinks noted along the body on the purple catheter of the oa-10 device captured under pr (b)(4) may have contributed to the advancement difficulties encountered with the clso-10-12.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.

Event Description

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

• 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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 14057860
• MDR Text Key: 298526336
• Report Number: 3001845648-2022-00209
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLSO-10-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2022
• Event Location: Hospital
• Date Manufacturer Received: 03/29/2022
• 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