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

Catalog Number TTSO-8.5-9

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User advanced the wire guide into common bile duct to conduct radiography, and detected there is stenosis of the lower common bile duct, then to place the ttso-8.5-9 stent but found out the outer catheter is smaller than stent.User then used another outer catheter to place the stent successfully."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.".

Manufacturer Narrative

Device evaluation: 1 x ttso-8.5-9 of lot number c1860616 was not returned to cirl for evaluation.Document review including ifu: prior to distribution all ttso-8.5-9 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 ttso-8.5-9 device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1860616.The instructions for use, ifu0045, which accompanies this device warns of the following ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ "introduce stent, tapered tip first, and positioning sleeve onto guiding catheter and pre-positioned".Root cause review: a definitive root cause could not be determined from the available information.The submitted image shows the outer catheter unable to pass over the stent.A possible root cause of the difficulty in advancing the catheter over the stent could be attributed to the user selecting the incorrect catheter length for the stent placement.Due to limited information and the device not being returned this will be assessed as a worst case scenario of user error, if additional information is received at a later date the file will be reopened and the investigation updated accordingly.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 follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

• 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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 14082809
• MDR Text Key: 298605448
• Report Number: 3001845648-2022-00217
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002222967
• UDI-Public: (01)10827002222967(17)240819(10)C1860616
• 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: 09/14/2022

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-8.5-9
• Device Lot Number: C1860616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: 30 YR
• Patient Sex: Male