FDA Adverse Event
Malfunction
Summary report: N
NAVIEN INTRACRANIAL CATHETER
MDR report key: 3140594
·
Received May 31, 2013
Report
- Report Number
- 2029214-2013-00503
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 14, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER FRACTURED AND WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240716 | NAVIEN INTRACRANIAL CATHETER | GUIDE CATHETER | DQY | EV3 NEUROVASCULAR | RFX072-105-08MP | 9722982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |