MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL COMVI STENT; PYLORIC & DUODENAL STENT

Model Number DCT2010BP

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that after the comvi stent was placed in second portion of duodenum, it was tended to be bleeding, and the surgeon assumed that bleeding was occurred by chemotherapy.It was also reported that there were no patient complications as a result of this event.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.According to device history records, there was no problem with that device.Surgeon assumed that the bleeding was not caused by using the stent.So, it is considered that the bleeding was not the patient outcomes caused by device malfunction.This suspected device is not registered in the u.S.We will continuously monitor the same or similar customer complaints.

Event Description

A 10cm of niti-s pyloric duodenal comvi stent was placed in second portion of duodenum through forecourt part of pylorus before.It was tended to be bleeding between proximally covered and flare, it was scheduled to place the covered stent (dct2010bp).During microscopy examination, the bleeding was observed, then cre balloon (18 - 20mm) was used to stop bleeding.Then dct2010bp was placed.(it was not sure the bleeding was completely stopped.) at the time, blood pressure dropped to 40 mmhg level.There is no additional information for patient status.The surgeon guesses that this case(bleeding) was not caused by stent placement because the patient had conducted chemotherapy after placement of initial stent and he considered that the bleeding was due to chemotherapy.There were no patient complications as a result of this event.

• Brand Name: NITI-S PYLORIC & DUODENAL COMVI STENT
• Type of Device: PYLORIC & DUODENAL 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: 6889439
• MDR Text Key: 87215606
• Report Number: 3003902943-2017-00036
• Device Sequence Number: 1
• Product Code: MUM
• 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: Other
• Type of Report: Initial
• Report Date: 09/12/2017

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: 04/27/2018
• Device Model Number: DCT2010BP
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• 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