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