FDA Adverse Event
Malfunction
Summary report: N
HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN)
MDR report key: 22901647
·
Received August 27, 2025
Report
- Report Number
- 3008146331-2025-00003
- Event Type
- Malfunction
- Date Received
- August 27, 2025
- Report Date
- August 27, 2025
- Manufacturer
- M.I.TECH CO., LTD.
- Product Code
- MUM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE HOSPITAL ALSO SUBMITTED A REPORT UNDER MAUDE ADVERSE EVENT REPORT. (MDR REPORT KEY: (B)(4) BASED ON THE DESCRIPTION, A DEPLOYMENT FAILURE OCCURRED DURING THE PROCEDURE. THE PRODUCT WAS NOT RETURNED, SO NO PHYSICAL EVALUATION WAS PERFORMED. THEREFORE, WE COULD NOT ASSUME THE ROOT CAUSE OF THE BREAKAGE OF THE PRODUCT AND THE DEPLOYMENT FAILURE.
Description of Event or Problem · 0
UNABLE TO USE STENT SINCE THE DEPLOYMENT STRING SNAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108266 | HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN) | HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN) | MUM | M.I.TECH CO., LTD. | DNJF-22-120-230 | 24082264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Hospitalization| R |