MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT

Model Number PDT2410

Device Problems Break (1069); Fracture (1260)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

We were not able to investigate manufacturing history records since the suspected device was not returned and serial no.Was not identified.Fracture, which can occur in other company's device as well as ours, is affected by patient's lesion status, peristalsis of organs, and drug use.It is, however, impossible to find out exact root cause since there is no patient information and it is difficult to reconstruct the situation at the time of procedure.It is impossible to identify the device history records without device returned it is, therefore, hard to determine that device was fractured by malfunction or defect.It is regarded that stent was fractured by patient's lesion status and it was rotated by peristalsis of organs and body fluid.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

(b)(6) 2016 - stent was inserted at duodenum.(b)(6) 2016 dr had rescoped that patient.The stent that was originally placed was found to have fractured and rotated causing complete bowel obstruction.The stent was unable to be removed.Three further stents deployed to rectify the obstruction.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC & DUODENAL 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: 6016045
• MDR Text Key: 56912263
• Report Number: 3003902943-2016-00031
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/13/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: PDT2410
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/11/2016
• 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