MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT

Model Number EST1810F

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

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

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the wire guide port at the proximal end was too restricted to allow wire to exit.The physician tried to poke a hole in it to allow the guide wire to go through but failed.As a result of analysis of returned device, the outer sheath was not detached and stent was fully deployed and not returned.Taewoong's 0.035inch guide wire was used for the passing test, and it was observed that it did not pass through the hub part.Inner sheath in the hub was pressed.After cutting the pusher and analyzing, it was observed that the inner was pressed and stretched.This device has successfully passed the manufacturing and inspection criteria as a result of confirmation of the dhr for the suspected device.It is difficult to identify the exact root cause since it is hard to recreate the situation at the time of procedure and the used guide wire was not returned though the information about used guide wire was provided.However, based on the pressed and stretched inner sheath in the pusher part, it is assumed that the guide wire got stuck in the hub part during the procedure in any reason, and it is caused to feel restriction by the user.And then, the inner was stretched when tried to pushed and pulled the guide wire by user to allow it to enter.This complaint couldn't know the root cause, but it is assumed that it was a malfunction of the device during the procedure, and there will be continued to monitor the same or similar customer complaints.

Event Description

Wire guide port at the proximal end too restricted to allow wire to exit.The customer tried to poke a hole in it to allow it go through and couldn't do that successfully.Customer ended up using stent anyway, so only the delivery system is available for return.Wire is a g25686.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 10789865
• MDR Text Key: 214801683
• Report Number: 3003902943-2020-00091
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K123205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2020

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 Expiration Date: 03/22/2023
• Device Model Number: EST1810F
• Device Catalogue Number: EST1810F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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