MAUDE Adverse Event Report: M.I.TECH CO.,LTD. HANAROSTENT ESOPHAGUS TTS (CCC); PROSTHESIS, ESOPHAGEAL

Model Number ECBA-20-100-180

Device Problem Entrapment of Device (1212)

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

Event Date 04/20/2021

Event Type  malfunction  

Event Description

Sales rep.(b)(6) called, and reported an issue, where the inner tube of the delivery system became lodged in a gif-1tq160 when the outer sheath was removed post stent deployment.

• Brand Name: HANAROSTENT ESOPHAGUS TTS (CCC)
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): M.I.TECH CO.,LTD.; pyeongtaek-si, gyoenggi-do ; KS
• Manufacturer (Section G): M.I.TECH CO., LTD.; pyeongtaek-si, gyoenggi-do ; KS
• Manufacturer Contact: danny lee ; suwon-si, gyeonggi-do ; KS
• MDR Report Key: 12305651
• MDR Text Key: 267637410
• Report Number: 3008146331-2021-00002
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08806367088482
• UDI-Public: 08806367088482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/28/2021

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: 11/02/2023
• Device Model Number: ECBA-20-100-180
• Device Catalogue Number: ECBA-20-100-180
• Device Lot Number: 20100290
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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