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

Model Number CDT1812

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that distal part of stent was bent over as a result of examination since patient couldn't defecate, therefore, bended stent was cut by apc which is argon plasma coagulation according to procedure description.It is impossible to identify the device history record without serial no.And device was already discarded in the hospital, therefore, it cannot be returned.Sigmoid colon structure where stent was implanted is curvy.In addition, patient had malignant stenosis.Therefore, stent was likely to be inserted as bended condition due to severe curve and stenosis.Reportedly, stent was most likely squashed up by feces.Stent that was a bit bended during insertion could have been severely bent over affected by feces.It is, however, impossible to identify the exact root cause since there are no medical pictures provided and device was discarded in the hospital it is, therefore, hard to recreate the situation at the time of procedure and post-procedure.We will continuously monitor whether similar or same complaint occurs.The suspected device is not registered to us fda and it has not been shipped into the us.

Event Description

(b)(6) 2015: (b)(4) was applied to malignant sigmoid colon stenosis as palliative treatment.(b)(6) 2015: patient claimed for having no feces.Patient underwent examination and distal stent end was found to be somewhat bent over.Since intestinal tract was obstructed as well, bent stent end was cut by apc (argon plasma coagulation).Reportedly, stent was most likely squashed up by feces.

• 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: 5488447
• MDR Text Key: 39934212
• Report Number: 3003902943-2016-00012
• 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: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/16/2016
• 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): Hospitalization