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

Model Number CDT2208

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Perforation (2001); Peritonitis (2252)

Event Date 02/05/2016

Event Type  Death  

Manufacturer Narrative

We couldn't investigate device history record and evaluate the device since the suspected device was not returned and no serial number was given.Perforation can occur by other company's device as well as ours and be affected by patient's medical condition including lesion condition, peristalsis of organs, and drug use.It is regarded that this adverse event was not caused by our stent based on ct scan result on which perforation was doubted at cecum prior to procedure and stent was applied to not cecum but transverse colon.It is hard to find out exact root cause for this complaint because it is difficult to reconstruct the situation at the time of procedure with limited information and no device returned.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

On (b)(6) 2016: tiny perforation as well as air inside colon was doubted from the ct scan result before procedure.Target lesion of stenting was transverse colon and tiny perforation doubted was in cecum.A cdt2208 was applied to a patient ((b)(6), female) with transverse colon stenosis as palliative care.1 hour after the procedure, patient claimed for abdominal pain as well as bloated feeling in stomach.On (b)(6) 2016: patient passed away because of peritonitis.Perforated area: cecum.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO., LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19960641
• MDR Report Key: 5832469
• MDR Text Key: 50712603
• Report Number: 3003902943-2016-00027
• 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: Other
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDT2208
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 93 YR