MAUDE Adverse Event Report: COOK IRELAND LTD ST-2 SOEHENDRA TANNENBAUM BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number TTSO-8.5-8

Device Problem Difficult to Advance (2920)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User cannot advanced the stent during procedure, and changed to another same device to complete the procedure."a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." for all complaints, ask: what is the reorder number of the wire guide used with this device? metii.If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with endoscope) also ask: had a sphincterotomy been performed prior to this occurrence? yes.What is the endoscope manufacturer and model number that was used? olympus 290.Please describe the location in the body where the stent was to be placed.Common bile duct.Was resistance encountered when advancing the wire guide through the obstructed area? yes.Was resistance encountered when advancing the introduction system in place? yes.Was resistance encountered when advancing the stent through the obstructed area? yes.After placement, was stent position verified? if yes, please describe how.X-ray.Please estimate amount of time the stent was in place prior to this occurrence.Did any section of the device detach inside the endoscope or patient? no.

Manufacturer Narrative

Device evaluation: 1 x ttso-8.5-8 of unknown lot number was not returned to cirl for evaluation.This file is linked to file which captures the difficult advancement of the oa-8.5.Document review including ifu: prior to distribution all ttso-8.5-8 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 could not be completed as the lot number is unknown.As per instructions for use, (ifu0045-7) a contraindications identified includes an ¿inability to pass wireguide or stent through obstructed area.¿.The user is also 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¿.Root cause review: a definitive root cause could not be determined as the device was not returned for evaluation.A possible root cause may be attributed to patient anatomy; the customer mentions a pre-existing condition of chronic choledochostenosis, this may or may not have been an aggravating factor of the advancement difficulty experienced.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: ST-2 SOEHENDRA TANNENBAUM BILIARY STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 13224472
• MDR Text Key: 286354114
• Report Number: 3001845648-2022-00008
• 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: TTSO-8.5-8
• 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: 11/10/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 12/15/2021
• 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
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 70 KG