FDA Adverse Event
Injury
Summary report: N
ONYX
MDR report key: 2981509
·
Received February 27, 2013
Report
- Report Number
- 2029214-2013-00178
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- January 30, 2013
- Report Date
- January 31, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 AVM (ARTERIOVENOUS MALFORMATION). AFTER INJECTION OF ONYX FOR 30 MINUTES WITH SEVERAL PAUSES IN BETWEEN, IT WAS REPORTED THAT THE ULTRAFLOW CATHETER RUPTURED. THE CATHETER WAS REMOVED FROM THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00177.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85700 | ONYX | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7000-060 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |