MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S HOT SPAXUS¿ STENT & ELECTROCAUTERY STENT DELIVERY SYSTEM; PANCREATIC STENT

Model Number HSS1602FW

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that during the stent deployment, external flare didn't open.Based on the attached photo, it is confirmed that the flare of the stent was not fully expanded.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Our nitinol wire, the raw material of stent, is shape-memory alloy.Generally, if the stenosis of a patient's lesion is severe, the stent expansion may require some time.However, it is difficult to identify the exact root cause because it is difficult to reconstruct the situation at the time of procedure.It is difficult to identify the exact root cause because the device was not returned, and it is difficult to reconstruct the situation at the time of procedure.However, based on flare of the stent was not fully expanded in the attached photo, it is assumed that the stent was not expanded temporarily due to the condition of the patient's lesion and other elements complexly.Through the user manual by taewoong, it is stated that it is stated that "a stent may require up to 1 to 3 days to expand fully and balloon dilatation inside the stent can be performed if the physician deems necessary".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

During the stent deployment, external flare didn't open, after struggling to open it with biopsy forceps and with endoscope, nothing happened, therefore we took it out and inserted one new system.

• Brand Name: NITI-S HOT SPAXUS¿ STENT & ELECTROCAUTERY STENT DELIVERY SYSTEM
• Type of Device: PANCREATIC 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, gyeonggi-do 10022
• MDR Report Key: 17805391
• MDR Text Key: 324118921
• Report Number: 3003902943-2023-00029
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: HSS1602FW
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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 Age: 46 YR
• Patient Sex: Male