FDA Adverse Event
Injury
Summary report: N
ECHELON MICRO CATHETER
MDR report key: 2063435
·
Received April 19, 2011
Report
- Report Number
- 2029214-2011-00080
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 23, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WAS RETURNED IN TWO SEGMENTS. EVALUATION CONFIRMED THAT THE CATHETER WAS BROKEN DUE TO EXCESSIVE TENSILE FORCES APPLIED DURING USE.(B)(4)
Description of Event or Problem · 1
TREATMENT OF AN AVM. IT WAS REPORTED THAT THE CATHETER BROKE OFF DURING ONYX INJECTION WITH APPROXIMATELY 45CM OF THE DISTAL SEGMENT STAYED IN THE PATIENT. THE BROKEN SEGMENT WAS SUCCESSFULLY RETRIEVED.NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2011-00081
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON MICRO CATHETER | DELIVERY CATHETER | KRA | EV3 NEUROVASCULAR | 105-5091-150 | 9409232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |