FDA Adverse Event
Injury
Summary report: N
ONYX
MDR report key: 3113737
·
Received May 15, 2013
Report
- Report Number
- 2029214-2013-00456
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 18, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- 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
DURING THE ONYX INJECTION, IT WAS REPORTED THAT IT WAS TAKING MORE TIME TO FORM THE PLUG AND IT BACKED UP IN THE CATHETER TO FORM PRESSURE CAUSING THE CATHETER TO RUPTURE WHEN THEY TRIED TO ADVANCE ADDITIONAL ONYX.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00455.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214905 | ONYX | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7100-060 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |