NOVOSTE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-27 for NOVOSTE * manufactured by Novoste Corp..

Event Text Entries

[20246634] During extraction, seeds got stuck in delivery system. Entire system removed from pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 546805
• MDR Report Key: 546805
• Date Received: 2004-09-27
• Date of Report: 2004-09-27
• Date of Event: 2004-09-23
• Date Facility Aware: 2004-09-23
• Report Date: 2004-09-27
• Date Reported to FDA: 2004-09-27
• Date Reported to Mfgr: 2004-09-27
• Date Added to Maude: 2004-10-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NOVOSTE
• Generic Name: NOVOSTE BETA CATH DELIVERY SYSTEM
• Product Code: MOU
• Date Received: 2004-09-27
• Model Number: *
• Catalog Number: *
• Lot Number: 712650
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 791153
• Manufacturer: NOVOSTE CORP.
• Manufacturer Address: 3890 STEVE REYNOLDS BLVD NORCROSS GA 30093 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-09-27