FDA Adverse Event
Malfunction
Summary report: N
NXT DETACHABLE COIL
MDR report key: 703436
·
Received April 21, 2006
Report
- Report Number
- 2029214-2006-00042
- Event Type
- Malfunction
- Date Received
- April 21, 2006
- Report Date
- March 23, 2006
- Manufacturer
- EV3, NEUROVASCULAR DIVISION
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DURING AN ANEURYSM COLLING PROCEDURE, PHYSICIAN DELIVERED A 2MM NXT COIL AND NOTED THE TIP OF THE COIL WAS PASS THROUGH THE STENT INTO THE PT'S PARAENT VESSEL. NO CONPLICATIONS WERE REPORTTED TO HAVE OCCURRED WITH THE OT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NXT DETACHABLE COIL | ELECTROLYTICALLY DETACHABLE COIL | HCG | EV3, NEUROVASCULAR DIVISION | * | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |