MAUDE Adverse Event Report: TAEWOONG MEDICAL.CO.,LTD ESOPHAGEAL TTS STENT; PROSTHESIS, ESOPHAGEAL

Model Number EST2010F

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2017

Event Type  malfunction  

Event Description

Patient came in for a procedure.Needed to have a duodenal stent placed.Doctor went to deploy the device, and it malfunctioned (it did not deploy correctly).He then attempted to deploy a 2nd stent and that device also malfunctioned.A third stent of a different type was successfully used.

• Brand Name: ESOPHAGEAL TTS STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): TAEWOONG MEDICAL.CO.,LTD; calley a. herzog; 3502 dundee drive; chevy chase MD 20815
• MDR Report Key: 7094996
• MDR Text Key: 94085967
• Report Number: 7094996
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EST2010F
• Device Catalogue Number: EST2010F
• Device Lot Number: 17D3682C7GE162
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2017
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 64 YR