FDA Adverse Event
Malfunction
Summary report: N
MARATHON MICRO CATHETER
MDR report key: 1062999
·
Received June 18, 2008
Report
- Report Number
- 2029214-2008-00114
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 19, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 23.8 CM FROM THE DISTAL TIP. THE CATHETER APPEARS TO HAVE RUPTURED DUE TO CATHETER OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION OF THE CATHETER, RESULTING IN PRESSURES EXCEEDING THE LIMITS OF THE CATHETER. THE IFU INCLUDES A WARNING "WHEN INJECTING CONTRAST FOR ANGIOGRAPHY, ENSURE THAT THE CATHETER IS NOT KINKED, PROLAPSED OR OCCLUDED". RESULTS: CATHETER RUPTURE.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER SPLIT. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER | FLOW-DIRECTED MICRO CATHETER | KRA | EV3 NEUROVASCULAR | 105-5055 | 4998922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |