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

Model Number EST1812F

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that difficult to confirm placement of device under fluoroscopy.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Our stents consist of the metallic stent, which was made of nitinol wire.In order to appropriately deploy the stent on the target position, x-ray marker inserted on the delivery system and platinum marker inserted on the proximal, distal part of stent, and also, it helps to trace after deployment.However, the outline of stent wire might not be seen properly under fluoroscopy, and/or the stent might be seen a little according to angle of fluoroscopy image and gas occurred into the human body, but, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure, and it does not know whether contrast medium use or not.Based on the description, which was written that "difficult to confirm placement of device under fluoroscopy", it is assumed that the stent was vaguely observed according to angle of fluoroscopy image or procedure situation.However, it is hard to identify the exact cause because the device was not returned and the information such as photo was not provided and hard to reconstruct the situation at the time of procedure.This complaint cannot be identified the exact cause, and there will be continued to monitor the same or similar customer complaints.

Event Description

Difficult to confirm placement of device under fluoroscopy.Double-channel scope, mod and manufacturer unknown.Customer proceeded with the complaint device and placed it successfully.Problem was only that they couldn't confirm placement through fluoroscopy; customer was only picking up radiopaque portions very faintly and this confused the physician amidst other moving anatomy.

• 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: 9710046
• MDR Text Key: 194841281
• Report Number: 3003902943-2020-00013
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• 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: 02/03/2020

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: 06/18/2022
• Device Model Number: EST1812F
• Device Catalogue Number: EST1812F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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