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

Model Number EST2006F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

Event Type  malfunction  

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.For "a.Patient information", we, taewoong and our distributor could not get more detail patient info because the hospital did not open the pt info such as "age at time of event", "date of birth", "sex" and "weight".

Event Description

The stent was attempted to be placed in the 2nd part of the duodenum.The lumen was tortuous.The fellow was operating the scope and doctor was deploying.Doctor encountered resistance and forced it resulting in the stent breaking.The deployment sheath at the collar apparently broke away from the internal deploying structure.The collar and the "y-connector" moved freely back and forth with no effect on the stent deployment.The stent was discarded by the facility.There were no patient complications as a result of this event.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; goyang-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon; goyang-si, gyeonggi-do ; 19960641
• MDR Report Key: 5048884
• MDR Text Key: 25152273
• Report Number: 3003902943-2015-00061
• 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: Not Applicable
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2016
• Device Model Number: EST2006F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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