FDA Adverse Event
Malfunction
Summary report: N
AXIUM DETACHABLE COIL
MDR report key: 1791581
·
Received July 27, 2010
Report
- Report Number
- 2029214-2010-00159
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- June 24, 2010
- Report Date
- June 29, 2010
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE TACK WELD ON THE PUSHER ASSEMBLY WAS FOUND BROKEN. THE BROKEN TACK WELD LIKELY CAUSED THE COIL TO DETACH.
Description of Event or Problem · 1
IT WAS REPORTED DURING COIL DELIVERY, RESISTANCE ENCOUNTERED. THE COIL WAS REMOVED AND FOUND STRETCHED. SUBSEQUENTLY, THE IMPLANT COIL DETACHED FROM THE PUSHWIRE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-2-1-HELIX | 8005430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |