MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD. NITI-S NAGI STENT; PANCREATIC DRAINAGE STENT

Model Number BS1603FW

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

It successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for this device.It was identified that stent was severely damaged during procedure via medical image.As a result of analysis of returned device, several spots were fractured on the proximal part of stent and silicone coating was severely damaged.It is considered that retrieval suture on the proximal part was fallen out based on returned device without suture.No fracture was found on distal part of stent without any damage on silicone coating, while proximal part was severely damaged.It is regarded that stent was pressured by circumstances during procedure such as patient's bended lesion, location of stent based on state of severely damaged stent prior to removal; it was fractured on the proximal part and it was damaged on the silicone coated part accordingly.However, it is impossible to identify the exact root cause since there is no information of patient and it is hard to recreate the situation at the time of procedure.There was no patient's injury caused by this fracture, however we decided to report mdr since there is possibility of injury in the future.The suspected device is not registered to u.S.Fda and it has not been shipped to u.S.Monitoring is being conducted for the similar case by this firm.

Event Description

On (b)(6) 2015 stent was implanted at pancreas/stomach.On (b)(6) 2015 when dr.Went to routinely remove the stent after three months he found it looking like this.The stent appears to have broken down inside the patient.He says it looks as if someone has tried to remove it by forceps but the patient has no record of being scoped by anyone else.He removed it fairly easily with a snare so as to not cause any further damage and did this with no injury to the patient.No adverse effect on the patient.

• Brand Name: NITI-S NAGI STENT
• Type of Device: PANCREATIC DRAINAGE 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: minyoung oh ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19960641
• MDR Report Key: 5253869
• MDR Text Key: 32461341
• Report Number: 3003902943-2015-00072
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2018
• Device Model Number: BS1603FW
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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 Age: 67 YR