GALILEO III *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-27 for GALILEO III * manufactured by Guidant.

Event Text Entries

[304924] At 6 pm on the day of event, user advanced source to artery and the source stopped in pathway. They immediately performed the emergency response procedure according to the mfr recommendations in the user manual. The active source was retracted in the cartridge. No pt problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028506
• MDR Report Key: 462273
• Date Received: 2003-05-27
• Date of Report: 2003-05-27
• Date of Event: 2003-05-22
• Date Added to Maude: 2003-05-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PHYSICIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GALILEO III
• Generic Name: SOURCE DELIVERY UNIT
• Product Code: MOU
• Date Received: 2003-05-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 451223
• Manufacturer: GUIDANT
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-05-27