FDA Adverse Event Malfunction Summary report: N

CASHMERE COMPLEX CERECYTE COIL

MDR report key: 1041334 · Received April 21, 2008

Report

Report Number
1041334
Event Type
Malfunction
Date Received
April 21, 2008
Date of Event
April 7, 2008
Report Date
April 21, 2008
Manufacturer
MICRUS ENDOVASCULAR CORP.
Product Code
HCG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WI, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

COIL DID NOT UNSHEATH PROPERLY DURING PREPARATION FOR USE IN PATIENT. ANOTHER COIL WAS SUBSTITUTED, AND PATIENT WAS NOT INJURED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CASHMERE COMPLEX CERECYTE COIL COIL HCG MICRUS ENDOVASCULAR CORP. CRC140615-30 F39924

Patients

Seq Age Sex Outcome Treatment
1 *