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

Model Number CDT2206

Device Problem Insufficient Information (3190)

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

Event Date 12/12/2014

Event Type  Death  

Manufacturer Narrative

We were not able to investigate device history record and evaluate the device since the suspected device was not returned and serial no.Was not provided.Perforation can occur by other company's device as well as ours affected by patient's medical condition including lesion status, peristalsis of organs, and drug use.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 the time of procedure with limited information.It was reported that perforation seemed to occur not because of quality of device but because of weakened patient's tissue on which procedure placed too much strain according to doctor's comment.It is, therefore, regarded as adverse event caused by patient's medical condition and procedure.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) 2014: cdt2206 was applied to a patient ((b)(6), female) with transverse colon stenosis as a bts.Right after procedure during x-ray inspection free air was admitted.Patient also claimed for abdominal pain so perforation during procedure was doubted.Emergency operation followed on the same day.Intestinal necrosis and pneumatosis intestinalis attributable to bowel ischemia were doubted from the ct scan result.On (b)(6) 2014: patient passed away because of peritonitis and small intestinal perforation.Perforation was in small intestine close to cecum.The procedure date was (b)(6) 2014, but this complaint was reported on 2016.07.13.It was recently held congress where distributor first heard of this ae and further hearings followed the other day.Doctor does not really attribute the quality of device to the cause of perforation, but the procedure itself.Doctor commented that procedure placed too much strain to the patient tissue that had become very fragile.

• 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: 5832442
• MDR Text Key: 50712474
• Report Number: 3003902943-2016-00026
• 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: 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: CDT2206
• 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: 84 YR