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

Model Number CDT1808

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Perforation (2001)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that another stenosis was found, but it was difficult to determine whether it was in the intestine or abdominal cavity by the contrast image or posture change, however, the physician finally determined that it was in the intestine.Therefore, the physician inserted the delivery system along with the gw and placed the stent, however, the patient complained about pain and then it was found that it was in the abdominal cavity by ct, leading to the emergency surgery at the end.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.There is no mention about any problem of the stent deployment and the device was not returned to us, so it is difficult to judge perforation caused by device malfunction.However, based on the description, which was written that "physician inserted the delivery system along with the gw and placed the stent, however, the patient complained about pain and then it (the stent, cdt1808) was found that it (the stent, cdt1808) was in the abdominal cavity by ct, leading to the emergency surgery at the end.", it is considered that it was possible that the perforation has occurred due to any external factors, and then, it has a possible that the part or all of cdt1808 stent was deployed toward the abdominal cavity, but it is hard to identify the exact cause due to the lack of information such as the photos and the location of the perforation occurrence.It is stated on user manual as follows.6.Potential complications.Procedural complications.Intestinal perforation.The suspected device is not registered in the us and there will be continued to monitor the same or similar customer complaints.

Event Description

A 22 mm colorectal stent was placed at sigmoid colon in the patient a week before, and another stenosis was found behind at this time.Therefore, the physician inserted the scope (olympus pcf) to the stenosis (in the transverse colon around hepatic flexure).Then, jag wire and mtw (contrast tube) were inserted over the stenosis for imaging.It was difficult to determine whether it was in the intestine or abdominal cavity by the contrast image or posture change, however, the physician finally determined that it was in the intestine because the contrast media did not widely spread and was moved the same as the contrast media when pressing from the body surface.Therefore, the physician inserted the delivery system along with the gw and placed the stent, however, the patient complained about pain and then it (the stent, cdt1808) was found that it (the stent, cdt1808) was in the abdominal cavity by ct, leading to the emergency surgery at the end.The physician commented that it was difficult to judge whether it was in the intestine or the abdominal cavity by contrast imaging, so there was no help for it.

• 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: 8853797
• MDR Text Key: 153066640
• Report Number: 3003902943-2019-00027
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: CDT1808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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