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

Model Number EC1812BH

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/22/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 during the procedure, both guidewire and delivery system were stuck and stent could not be deployed.Bleeding was pretty excessive and concerning the risk of infection, the device used was discarded by the hosp.

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed actual eval.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.There is no patient's info, and since it is difficult to reconstruct the situation at that time in the lab and limited info, it is hard to find out exact root cause for this complaint.And we will continue the complaints to be monitored for same case.This report is a retrospective report due to a fda foreign inspection warning letter.The suspected device is not registered to us fda and it has not been shipped into the us.

• Brand Name: NITI-S ESOPHAGEAL COVERD STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon; gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 4871878
• MDR Text Key: 6063420
• Report Number: 3003902943-2015-00038
• 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: 10/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2016
• Device Model Number: EC1812BH
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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