FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 3121707
·
Received May 21, 2013
Report
- Report Number
- 2029214-2013-00483
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- February 28, 2013
- Report Date
- April 26, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DYG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- 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
DURING THE ONYX INJECTION, IT WAS REPORTED THAT THE MICROCATHETER RUPTURED 10 CM FROM THE DISTAL END. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00484.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223888 | MARATHON MICRO CATHETER | FLOW-DIRECTED MICRO CATHETER | DYG | EV3 NEUROVASCULAR | 105-5055 | 9685620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |