FDA Adverse Event
Injury
Summary report: N
ONYX
MDR report key: 3002755
·
Received March 13, 2013
Report
- Report Number
- 2029214-2013-00236
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 13, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. (B)(4).
Description of Event or Problem · 1
TREATMENT OF AN EXTERNAL CAROTID ARTERY AVM (ARTERIOVENOUS MALFORMATION). DURING ONYX INJECTION, IT WAS REPORTED THAT ONYX WAS OBSERVED COMING OUT FROM THE FARGO GUIDE CATHETER AND NOT THE DISTAL TIP OF THE ECHELON CATHETER. A HOLE WAS NOTICED ON THE ECHELON CATHETER ONCE IT WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00235.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105617 | ONYX | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7000-060 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |