MAUDE Adverse Event Report: SEWOON MEDICAL CO., LTD. BONASTENT ESOPHAGEAL STENT; PROSTHESIS, ESOPHAGEAL

Model Number BER

Device Problem Misfire (2532)

Patient Problem No Information (3190)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

We have completed the investigation for the returned product, but we have not find any defectiveness.Stent of the returned product was come out of the delivery device and fully deployed.We have reviewed device history record for the same lot number as the returned product, and we confirmed that there was no problem in the manufacturing process.We also have not received any complaints from the same batch.We have performed repositioning test for the product we have.After pulling handle up to red marking line, pushed handle again up to the first position.We have confirmed that repositioning was operating normally in this test.Repositioning can be operating only when the handle of the delivery device must be between red marker and distal black marker.Repositioning could not be operating if the user pull handle of delivery device beyond red marker.

Event Description

It was reported that the stent was "misfired/unable to recapture".It was not reported if this malfunction caused injury or other negative health consequence to any patient.

• Brand Name: BONASTENT ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): SEWOON MEDICAL CO., LTD.; seoul ; KS
• Manufacturer Contact: tae cho ; 46 wangsan-ro, dongdaemum-gu; seoul ; KS ; 9226555
• MDR Report Key: 5159645
• MDR Text Key: 28709831
• Report Number: 3000247987-2015-00002
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 09/17/2015

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: 09/14/2017
• Device Model Number: BER
• Device Catalogue Number: DU-BER-1808
• Device Lot Number: 140915
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/20/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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