FDA Adverse Event
Malfunction
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 2063386
·
Received April 19, 2011
Report
- Report Number
- 2029214-2011-00078
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 28, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER HAS BEEN EVALUATED AND A SEPARATION WAS CONFIRMED AT APPROXIMATELY 88.3 CM FROM THE DISTAL TIP OF THE CATHETER. CATHETER SEPARATED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS FOUND FRACTURED OUT OF THE PACKAGE. THE DEVICE WAS NOT USED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW DIRECTED MICRO CATHETER | DYG | EV3 NEUROVASCULAR | 105-5055 | 8421484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |