MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD NITI-ENTERAL COLONIC UNCOVERED STENT

Model Number CDT2206

Device Problems Unraveled Material (1664); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

Cdt2206 was applied to a patient's sigmoid colon.Physician encountered no resistance during the deployment and no resistance during delivery system removal either.After implanted, physician admitted stent cell on the proximal end somehow deformed.Cdt2206 implanted lesion is confirmed patent, this patient is now kept under a follow-up.No patient complications reported so far as a result of this event.

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.We will continuously monitor whether similar or same complaint occurs.

• Brand Name: NITI-ENTERAL COLONIC UNCOVERED STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si,goyang-si, kyunggi-do ; KS
• Manufacturer Contact: 14-1,gojeong-ro, wolgot-myeon, gimpo-si; gyeonggi-do, ; 19960641
• MDR Report Key: 4921986
• MDR Text Key: 19346862
• Report Number: 3003902943-2015-00051
• Device Sequence Number: 1
• Product Code: MQR
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: CDT2206
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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: 72 YR