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

Model Number CXDT2212

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that after transanal ileus tube was placed, cxdt2212 was placed.However, the distal part of the stent was found placed in the abdominal cavity.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Based on the description "reviewing ct image and fluoroscopic x-ray image when the transanal ileus tube was placed, the physician commented that it was likely to be perforated when placing the transanal ileus tube and then the transanal ileus tube was also placed partially in the abdominal cavity.", it is considered the transanal ileus tube was placed in the abdominal cavity due to user mistake, and following this the stent was also placed partially in the abdominal cavity.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) 2022: a transanal ileus tube was placed.After the tube placement, the irritative symptom of peritoneum could not be seen for the following two days, but decompression after the tube placement was not sufficient.On (b)(6) 2022: gw was inserted into the transanal ileus tube, and the transanal ileus tube was removed.After that, the physician placed cxdt2212 there and the procedure was finished.During the contrast imaging after the procedure, the abdominal cavity was imaged, so ct image was taken to check.Then, the mouth side of the stent was found being placed in the abdominal cavity.Reviewing ct image and fluoroscopic x-ray image when the transanal ileus tube was placed, the physician commented that it was likely to be perforated when placing the transanal ileus tube and then the transanal ileus tube was also placed partially in the abdominal cavity.The physician determined to construct an artificial anus because the endoscopic treatment was hard.

• 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: 15452801
• MDR Text Key: 300225416
• Report Number: 3003902943-2022-00027
• 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: 08/26/2022

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 Model Number: CXDT2212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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