FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 1032528
·
Received April 22, 2008
Report
- Report Number
- 2029214-2008-00077
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 29, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DYG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT IS BEING HELD AT THE HOSPITAL.
Description of Event or Problem · 1
DURING AN EMBOLIZATION OF A VEIN OF GALEN ANEURYSM, THE CATHETER WAS PLACED IN THE RIGHT ANTERIOR CEREBRAL ARTERY. DURING ONYX INJECTION, IT WAS REPORTED THE PHYSICIAN NOTED ONYX WAS PRESENT IN THE ARTERY. THE CATHETER WAS REMOVED AND FOUND RUPTURED. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULTED OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW DIRECTED MICRO CATHETER | DYG | EV3 NEUROVASCULAR | 105-5055 | 2417852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Disability |