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

Model Number EST2015F

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270); Activation Problem (4042)

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

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that while attempting to deployment, the handle became stuck.With more force there was a cracking sound.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Resistance can be felt due to pressure generated by patient's lesion during deployment.Outer sheath can be stretched and detached so it can cause deployment failure if deployment was tried by force in this situation.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is impossible to identify the exact cause because the device was not returned.However; based on the description which was written that "while attempting to deployment, the handle became stuck.With more force there was a cracking sound", it is considered that delivery system was pressured due to patient's lesion during procedure and deployment was tried in that situation.It was hard to deploy due to pressure sheath, and the strong resistance occurred and the outer sheath was detached in the end, resulting in deployment failure.This complaint is assumed that it was malfunction due to pressed by patient's lesion, there will be continued to monitor the same or similar customer complaints.

Event Description

Stent placed from ge junction to gastric pylorus.While attempting to deployment, the handle became stuck.With more force there was a cracking sound.At no point was part of the stent deployed from delivery device.Stent and scope were removed from the patient.The procedure was completed another stent.According to gi tech who assisted doctor, confirmed that safety dial lock was unlocked prior to the deployment.Device was not saved.

• 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: 15010184
• MDR Text Key: 302930019
• Report Number: 3003902943-2022-00014
• 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: 06/18/2022

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 Expiration Date: 10/27/2022
• Device Model Number: EST2015F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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