FDA Adverse Event
Injury
Summary report: N
ECHELON 14 MICRO CATHETER
MDR report key: 1030841
·
Received April 17, 2008
Report
- Report Number
- 2029214-2008-00070
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 19, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- 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 HAS BEEN SEPARATED FROM THE CATHETER AND STAYED ON THE IMPLANT COIL. BASED ON THE INVESTIGATION, THE SEPARATION OF THE DISTAL TIP/MARKER BAND IS LIKELY TO HAVE OCCURRED AS A RESULT OF SHAPING THE TIP OF THE CATHETER.
Description of Event or Problem · 1
AFTER COIL DETACHMENT, IT WAS REPORTED THAT THE CATHETER TIP SEPARATED WITH THE COIL. THE ENTIRE SYSTEM WAS REMOVED FROM THE PT, INCLUDING THE COIL. THE CATHETER WAS REPORTED TO HAVE BEEN STEAM SHAPED PRIOR TO USE. THE PT WAS REPORTED TO HAVE AN INFARCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 14 MICRO CATHETER | DELIVERY CATHETER | KRA | EV3 NEUROVASCULAR | 105-5092-150 | 1679168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |