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

Model Number ESP2410FD

Device Problems Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/28/2015

Event Type  Injury  

Event Description

The doctor used a niti-s esophageal covered stent (double type) with a proximal release.He had positioned the stent and delivery system in the correct position, deployment was smooth and the stent was deployed in the position required.When the doctor began removing the delivery system, he noticed it was stuck and when pulled back, the stent would move with it and therefore when pulled back with more force, the stent was fully removed from the position.When the doctor reached the first part of the esophagus, the delivery system broke in half, leaving the doctor to remove the remaining part with his hands.The stent was fully removed and the procedure was unsuccessful.

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.But, it is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.It is hard to find out exact root cause for this complaint, because the suspected device was not returned and it is difficult to reconstruct the situation at that time in the lab and limited info.We will continuously monitor whether similar or same complaint occurs.The suspected device is not registered to us fda and it has not been shipped into the us.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do, ; KS
• Manufacturer Contact: 14, gjeong-ro; wolgot-myeon, gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 4921995
• MDR Text Key: 6027241
• Report Number: 3003902943-2015-00053
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/23/2015

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: 02/17/2017
• Device Model Number: ESP2410FD
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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 Outcome(s): Hospitalization