MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ENTERAL COLONIC UNCOVERED STENT; COLONIC STENT

Model Number CDT2210

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

It was reported that free air was observed after 1 week from the stent implantation.The stent is not removed from the patient.The surgeon suspected that the free air might have occurred due to the perforation.The air was to be reduced, so the patient was treated medication and the surgeon decided that it needs the follow-up instead of additional surgical intervention.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Perforation can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.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 the time of procedure.The suspected device was not removed from the patient, so it is difficult to judge perforation caused by device malfunction.It is considered that perforation was occurred due to complexity of patient's lesion status and stent implantation.This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

Cdt2210 was placed at stenosis of sigmoid colon where about 8cm distal from the anus.Then it was reported that there was observed free air past about 1 week from the procedure.The patient was treated medication and the air was to be reduced, so the surgeon decided that it need the follow-up instead of additional surgical intervention.There were no patient complications as a result of this event.The surgeon commented that the free air might have occurred due to the perforation caused to stent expansion.It was not sure where was punched.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 6878233
• MDR Text Key: 86700498
• Report Number: 3003902943-2017-00030
• Device Sequence Number: 1
• Product Code: MQR
• 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: Other
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2019
• Device Model Number: CDT2210
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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