FDA Adverse Event
Malfunction
Summary report: N
ECHELON MICRO CATHETER
MDR report key: 1708006
·
Received May 28, 2010
Report
- Report Number
- 2029214-2010-00100
- Event Type
- Malfunction
- Date Received
- May 28, 2010
- Date of Event
- August 24, 2009
- Report Date
- April 30, 2010
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. IT WAS REPORTED THE USER DOES NOT KNOW WHICH OF THE LOT NUMBERS BELOW WAS THE INVOLVED DEVICE. MODEL# 145-5092-150, LOT # 4218940, DOM 10/26/2007, EXPIRATION 10/1/2009.
Description of Event or Problem · 1
TREATMENT OF AN AVM. IT WAS REPORTED DURING CATHERIZATION. THE PROXIMAL MARKER ON THE CATHETER WAS NOTICED MISSING. THE CATHETER WAS REMOVED FROM THE PATIENT AND THE DISTAL MARKER WAS FOUND NOT PRESENTED ON THE CATHETER. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON MICRO CATHETER | DELIVERY CATHETER | KRA | EV3 NEUROVASCULAR | 190-5092-150 | 3556024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |