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

Model Number CXDT2208

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Perforation (2001)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that during the procedure the doctor mistakenly pierced the colonic wall with the guide wire, and the stent was placed coming out of large intestine and it was perforated.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 "after inserting the gw, contrast imaging was done but it could not be found prior to inserting the delivery system because the image was not clear due to stool and thought it was a lumen by mistake", "gw pierced the colonic wall during insertion, and the stent was placed", "the perforation was due to a technical error and not due to product related factor" and "patient complained of stomach pain, an emergency surgery was performed", it is considered that the image of the stenosis area was not clear due to stool and the user mistakenly pierced the colonic wall with the guide wire during insertion, and the stent was placed, leading to the stent placed coming out of large intestine and was perforated.It is considered that this caused the patient to have stomach pain, therefore emergency surgery was performed to remove the stent.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: perforation, pain.' 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

There was a stenosis like pin hole size at sigmoid colon.Gw was inserted and the stent was placed.After that, the stent was found being placed coming out of large intestine and it was perforated.As the patient complained of stomach pain, an emergency surgery was performed, and the patient is under recovery now.The physician commented that the gw pierced the colonic wall during insertion, and the stent was placed along with the gw.After inserting the gw, contrast imaging was done but it could not be found prior to inserting the delivery system because the image was not clear due to stool and thought it was a lumen by mistake.The physician also commented that the perforation was due to a technical error and not due to product related factor.

Manufacturer Narrative

It was reported that during the procedure the doctor mistakenly pierced the colonic wall with the guide wire, and the stent was placed coming out of large intestine and it was perforated.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 "after inserting the gw, contrast imaging was done but it could not be found prior to inserting the delivery system because the image was not clear due to stool and thought it was a lumen by mistake", "gw pierced the colonic wall during insertion, and the stent was placed", "the perforation was due to a technical error and not due to product related factor" and "patient complained of stomach pain, an emergency surgery was performed", it is considered that the image of the stenosis area was not clear due to stool and the user mistakenly pierced the colonic wall with the guide wire during insertion, and the stent was placed, leading to the stent placed coming out of large intestine and was perforated.It is considered that this caused the patient to have stomach pain, therefore emergency surgery was performed to remove the stent.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: perforation, pain.' 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

There was a stenosis like pin hole size at sigmoid colon.Gw was inserted and the stent was placed.After that, the stent was found being placed coming out of large intestine and it was perforated.As the patient complained of stomach pain, an emergency surgery was performed, and the patient is under recovery now.The physician commented that the gw pierced the colonic wall during insertion, and the stent was placed along with the gw.After inserting the gw, contrast imaging was done but it could not be found prior to inserting the delivery system because the image was not clear due to stool and thought it was a lumen by mistake.The physician also commented that the perforation was due to a technical error and not due to product related factor.

• 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: 13082942
• MDR Text Key: 285189474
• Report Number: 3003902943-2021-00051
• 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: 12/07/2021

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: 08/05/2024
• Device Model Number: CXDT2208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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