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