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

Model Number CXDT2208

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the deployment was successful; however, one day after, the anal side of stent was found being not extended.It is hard to review suspected device's dhr, because it is not confirmed serial no.Colon structure where stent was implanted is curvy.Also, based on the description about receipt the deployment fail, which was written that "physician encountered very strong resistance", it seems that it was hard to expand successfully due to pressed by the patient's lesion condition.However, it is hard to identify the exact cause because there is no disease information for the patient and no photo information from the time of the procedure.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

On (b)(6) 2018: cxdt2208 was placed in the patient.On (b)(6) 2018: the anal side of cxdt2208 stent was found being not extended.Another stent (niti-s) was used to finish the procedure but it had stent deployment failure.

• 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: 8132122
• MDR Text Key: 129888549
• Report Number: 3003902943-2018-00032
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2018

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 Model Number: CXDT2208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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