FDA Adverse Event
Death
Summary report: N
SAPPHIRE HELIX SOFT DETACHABLE COIL
MDR report key: 514430
·
Received March 4, 2004
Report
- Report Number
- 2029214-2004-00009
- Event Type
- Death
- Date Received
- March 4, 2004
- Date of Event
- November 22, 2003
- Report Date
- March 4, 2004
- Manufacturer
- MICRO THERAPEUTICS, INC.
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING EMBOLIC COIL DELIVERY, THE COIL BROKE WHILE IN THE CATHETER. A SNARE WAS USED TO RETRIEVE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAPPHIRE HELIX SOFT DETACHABLE COIL | EMBOLIC COIL | HCG | MICRO THERAPEUTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death| R |