FDA Adverse Event
Death
Summary report: N
NEEDLE'S EYE SNARE
MDR report key: 510426
·
Received February 5, 2004
Report
- Report Number
- 2522007-2004-00001
- Event Type
- Death
- Date Received
- February 5, 2004
- Date of Event
- January 2, 2004
- Report Date
- January 7, 2004
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- MFA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DOCTOR TRIED SEVERAL TIMES TO GRASP/WITHDRAW THE LINE, WHICH RESULTED IN AN EMBOLUS IN THE LEFT VENTRICLE AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEEDLE'S EYE SNARE | CATHETER RETRIEVAL DEVICE | MFA | COOK VASCULAR INC. | LR-NES002 | 35772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Death |