FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER AND ONYX AVM
MDR report key: 1545961
·
Received November 23, 2009
Report
- Report Number
- 2029214-2009-00309
- Event Type
- Injury
- Date Received
- November 23, 2009
- Date of Event
- October 26, 2009
- Report Date
- October 29, 2009
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. MODEL # AND LOT # OF THE ONYX USED: MODEL #: 105-7000-060. LOT #: 6950553, 6962704, 7516733, 7516815. DOM: 01/2009, 01/2009, 06/2009, 06/2009. EXPIRATION DATE: 03/2010, 12/2011, 06/2012, 05/2012.
Description of Event or Problem · 1
IT WAS REPORTED THE AVM WAS TREATED WITH FOUR VIALS OF ONYX. AT THE END OF THE TREATMENT, IT WAS REPORTED THE CATHETER BROKE UPON RETRIEVAL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN SEGMENT WITH A GOOSE NECK SNARE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER AND ONYX AVM | FLOW-DIRECTED MICRO CATHETER AND LIQUID EMBOLIC | KRA | EV3 NEUROVASCULAR | 105-5055 | 7046848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |