FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 1250673
·
Received December 3, 2008
Report
- Report Number
- 2029214-2008-00201
- Event Type
- Injury
- Date Received
- December 3, 2008
- Date of Event
- October 10, 2008
- Report Date
- November 4, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
TREATMENT OF AN AVM WITH GLUBRAN. IT WAS REPORTED A HOLE WAS NOTICED ON THE CATHETER'S SHAFT DURING GLUE INJECTION. GLUE PASSED THROUGH THE HOLE AND WAS SUCCESSFULLY RETRIEVED WITH A GOOSENECK SNARE. 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 | 2221804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |