FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 1556455
·
Received December 8, 2009
Report
- Report Number
- 2029214-2009-00325
- Event Type
- Injury
- Date Received
- December 8, 2009
- Date of Event
- June 5, 2009
- Report Date
- August 12, 2009
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION. MODEL# AND LOT # OF THE ONYX USED: MODEL# 105-7100-060, LOT# 7279662 (QTY: 3EA). DOM 03/2009. EXPIRATION DATE 12/2011.
Description of Event or Problem · 1
TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THE PHYSICIAN EMBOLIZED 3 FEEDERS OF THE AVM USING 5 MARATHON CATHETERS AND APPROXIMATELY 0.58ML OF ONYX. ONE OF THE CATHETERS WAS REPORTED OCCLUDED AND BROKEN DURING ONYX INJECTION. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW-DIRECTED MICRO CATHETER | KRA | EV3 NEUROVASCULAR | 105-5055 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |