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

Model Number CXDT2212

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

Patient Problem Vomiting (2144)

Event Date 01/20/2022

Event Type  Injury  

Event Description

Stent placement for ileus, procedure for bts to chemotherapy.(b)(6) 2022: the stent was placed.(b)(6) 2022: the patient complaining of vomiting.During endoscopy, the stent was found being placed in transverse colon jejunal fistula, where was missed to be checked under ct.Depression was done by placing nb tube in ascending colon through the stent mesh as there was no leakage.The following actions to be discussed with surgeon.Considering the chemotherapy and performing a surgery for total removal and stoma.Physician's comment: it was a technical error (missed to check), there was a difference in the route of gw monitored on 2022/1/17 in advance and the route done on 2022/1/19.No product complaint is included.There were no patient complications as a result of this event.Additional information on 2022.02.15.The stent placed in transverse colon jejunal fistula was removed in the surgery at the beginning of feb.The fistula was excised, and the anastomosis of jejunum and colon was finished in that surgery.The patient is still in the hospital and the condition is currently good.

Manufacturer Narrative

It was reported that the stent was placed in transverse colon jejunal fistula and not the transverse colon by error, and the patient complained of vomiting.The stent was removed by surgery.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the description "the stent was found being placed in transverse colon jejunal fistula, where was missed to be checked under ct" and "it was a technical error (missed to check), there was a difference in the route of gw monitored on 2022/1/17 in advance and the route done on 2022/1/19.No product complaint is included.", it is considered the stent was placed in an unintended area due to error caused by failure to check under ct.This caused the patient to complain of vomiting, and the stent was removed through surgery.This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

• 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, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 13539670
• MDR Text Key: 290401068
• Report Number: 3003902943-2022-00005
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• 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: 01/25/2022

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: 04/08/2024
• Device Model Number: CXDT2212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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