FDA Adverse Event
Malfunction
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 2881519
·
Received December 20, 2012
Report
- Report Number
- 2029214-2012-00744
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Report Date
- November 27, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MARATHON CATHETER GOT STUCK DURING THE PROCEDURE. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW-DIRECTED MICRO CATHETER | DYG | EV3 NEUROVASCULAR | 105-5055 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |