FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 2222655
·
Received August 25, 2011
Report
- Report Number
- 2029214-2011-00223
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 26, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DYG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
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
TREATMENT OF AN AVM. IT WAS REPORTED THE CATHETER LEAKED DURING ONYX INJECTION. UPON REMOVAL, THE CATHETER BROKE OFF AND THE BROKEN SEGMENT REMAINED IN THE PATIENT. IT WAS REPORTED THE PATIENT EXPERIENCED AN EMBOLIC STROKE. SAME EVENT AS MDR# 2029214-2011-00224.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW DIRECTED MICRO CATHETER | DYG | EV3 NEUROVASCULAR | 105-5055 | 9331668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| S |