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

Model Number DDT2210

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Peritonitis (2252)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.But, it is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.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 that time in the lab and limited info.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.We will continuously monitor whether similar or same complaint occurs.

Event Description

It was reported that physician applied ddt2210 to a stricture caused by malignant tumor.Gw first reached the lesion and when ds was following up to the lesion, perforation was admitted at the site of duodenal bulb.Reportedly, gw had reached the second portion and ds was following the gw up to the duodenal bulb, but ds could not go further.Ds was once removed and re-flushed.At the second trial, it still did not go over the duodenal bulb and when physician pushed it harder, it perforated together with the gw.Reportedly, there were no sudden and severe change in patient's condition after perforation, but elevated levels of crp were confirmed (crp 12.0/dl) as hematological findings, which was diagnosed as peritonitis.Patient's been kept under a follow-up.Physician's comment: technical error cannot be denied.

Manufacturer Narrative

It was reported that delivery system did not go over the duodenal bulb and when physician pushed it harder, it perforated together with the gw.As a result of analysis of returned device, delivery system was returned with loaded stent, but the guide wire was not returned.There was curve on stent loaded part.Deployment was tried without pressure, but it failed.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, however, hard to find out exact root cause for this complaint because it is difficult to reconstruct the situation at the time of procedure.According to complaint product description, when physician pushed it harder, it perforated together with the gw.It is considered that delivery system did not go over the duodenal bulb due to severe stricture, then physician pushed it harder; it perforated together with the gw, in the end.There was insufficient procedure information at that time and no patient info.So it is impossible to identify the exact root cause.Since there was no problem at device history record, it is difficult to judge as perforation caused by device malfunction.However, considering given procedure information and device history records, it is considered that perforation was caused by physician's technical error rather than device malfunction.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

It was reported that physician applied ddt2210 to a stricture caused by malignant tumor.Gw first reached the lesion and when ds was following up to the lesion, perforation was admitted at the site of duodenal bulb.Reportedly, gw had reached the second portion and ds was following the gw up to the duodenal bulb, but ds could not go further.Ds was once removed and re-flushed.At the second trial, it still did not go over the duodenal bulb and when physician pushed it harder, it perforated together with the gw.Reportedly, there were no sudden and severe change in patient's condition after perforation, but elevated levels of crp were confirmed (crp 12.0/dl) as hematological findings, which was diagnosed as peritonitis.Patient's been kept under a follow-up.Physician's comment: technical error cannot be denied.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED 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 park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19906441
• MDR Report Key: 6224622
• MDR Text Key: 63911463
• Report Number: 3003902943-2017-00003
• 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,Followup
• Report Date: 12/27/2016

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: 07/19/2019
• Device Model Number: DDT2210
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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