FDA Adverse Event
Injury
Summary report: N
ECHELON MICRO CATHETER
MDR report key: 3232828
·
Received July 18, 2013
Report
- Report Number
- 2029214-2013-00611
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- May 22, 2013
- Report Date
- June 20, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS A PORTION OF IT REMAINS IN THE PATIENT.(B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM MEDWATCH# (B)(4).AFTER THE EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE ECHELON CATHETER FRACTURED AS IT WAS BEING RETRIEVED AND THE BROKEN SEGMENT REMAINED IN 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 |
|---|---|---|---|---|---|---|---|
| 335079 | ECHELON MICRO CATHETER | DELIVERY CATHETER | KRA | EV3 NEUROVASCULAR | 105-5091-150 | 9720907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |