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

Model Number CDT1812

Device Problem Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Perforation (2001)

Event Date 07/08/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, patient received colonic stent implantation.After implantation (specific date unknown) the patient started to receive xelox therapy.On (b)(6) 2014, perforation of the sigmoid colon was admitted and hartmann's operation was conducted.Reportedly, perforated area was the center of stent, center of cancer.The patient is still under xelox therapy, but is making satisfactory progress.Doctor attributes this perforation to the xelox therapy being effective.(chemotherapy being effective enough to shrink tumor).

Manufacturer Narrative

Perforation from patient's condition is one of well-known side effect.For this issue, it is documented in the product's user manual.However, the suspected device is not registered to us fda and it has not been shipped into us.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro; wolgot-myeon, gimpo-si, gyeonggi-do ; 9960641
• MDR Report Key: 4620877
• MDR Text Key: 5591962
• Report Number: 3003902943-2014-00026
• 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: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2016
• Device Model Number: CDT1812
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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 Outcome(s): Hospitalization; Life Threatening
• Patient Age: 73 YR