FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 2180208
·
Received July 27, 2011
Report
- Report Number
- 2029214-2011-00197
- Event Type
- Injury
- Date Received
- July 27, 2011
- Date of Event
- June 15, 2010
- Report Date
- June 27, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DYG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION.(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S AVM WAS TREATED WITH TEN VIALS OF ONYX VIA EIGHT MARATHON CATHETERS. DURING PROCEDURE, A SMALL SUBARACHNOID BLEED WAS OBSERVED DUE TO VESSEL PERFORATION FROM CATHETERIZATION. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW DIRECTED MICRO CATHETER | DYG | EV3 NEUROVASCULAR | 105-5055 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |