FDA Adverse Event
Malfunction
Summary report: N
ECHELON 10 MICRO CATHETER
MDR report key: 1200045
·
Received October 15, 2008
Report
- Report Number
- 2029214-2008-00182
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 16, 2008
- Report Date
- September 25, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE DISTAL TIP/MARKER BAND WAS NOT PRESENT ON THE DEVICE. BASED ON THE FINDINGS, THE CATHETER TIP LIKELY SEPARATED DURING THE REMOVAL OF THE DEVICE FROM THE PACKAGE PRIOR TO USE. THIS CAN OCCUR WHEN THE USER DOES NOT PROPERLY REMOVE THE DEVICE FROM THE TIP PROTECTOR. THE LABEL ON THE DEVICE TRAY PROVIDES INSTRUCTIONS/DIAGRAMS REGARDING THE REMOVAL OF THE TIP FROM THE TIP PROTECTOR.
Description of Event or Problem · 1
DURING PREPARATION, IT WAS REPORTED THE CATHETER'S TIP WAS NOT PRESENTED ON THE CATHETER. THE DEVICE WAS NOT USED ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 10 MICRO CATHETER | DELIVERY CATHETER | KRA | EV3 NEUROVASCULAR | 190-5091-150 | 3517700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |