FDA Adverse Event
Injury
Summary report: N
ECHELON MICRO CATHETER
MDR report key: 1913743
·
Received November 23, 2010
Report
- Report Number
- 2029214-2010-00249
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 29, 2010
- Report Date
- October 29, 2010
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVAL. (B)(4).
Description of Event or Problem · 1
TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THE CATHETER WAS USED TO DELIVER ONYX WITH APPROXIMATELY 2 CM OF ONYX REFLUX. AT THE END OF THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE CATHETER. THE PHYSICIAN CONTINUED TO PULL THE CATHETER AND IT BROKE. THE BROKEN SEGMENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. NO PT INJURY REPORTED. SAME EVENT AS MDR # 2029214-2010-00250.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON MICRO CATHETER | DELIVERY CATHETER | KRA | EV3 NEUROVASCULAR | 105-5091-150 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |