FDA Adverse Event
Malfunction
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1203576
·
Received October 16, 2008
Report
- Report Number
- 2029214-2008-00185
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 24, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EVALUATED AND THERE WAS A LARGE AMOUNT OF BLOOD FOUND IN THE CATHETER'S LUMEN; THIS LIKELY LED TO THE COIL GOT STUCK INSIDE THE CATHETER. (B) (4).
Description of Event or Problem · 1
COILING TREATMENT OF AN ANEURYSM. DURING COIL DELIVERY, IT WAS REPORTED AFTER APPROXIMATELY 1CM OF THE COIL EXITING THE TIP OF THE CATHETER, THE COIL COULD NOT BE PUSHED OR PULLED FOR REPOSITIONING. UPON REMOVAL, THE COIL PULLED OUT A PREVIOUSLY IMPLANTED COIL. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-3-4-3D | 6529564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |