3.5F BETA-RAIL DELIVERY CATHETER P02578 ABR-0346

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-03-31 for 3.5F BETA-RAIL DELIVERY CATHETER P02578 ABR-0346 manufactured by Novoste Corp..

MAUDE Entry Details

• Report Number: 1062385-2005-00002
• MDR Report Key: 602158
• Report Source: 05,06
• Date Received: 2005-03-31
• Date of Report: 2004-11-18
• Date of Event: 2004-11-05
• Date Mfgr Received: 2004-11-18
• Date Added to Maude: 2005-05-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Contact: MIKE SILVA
• Manufacturer Street: 4350 INTERNATIONAL BLVD
• Manufacturer City: NORCROSS GA 30093
• Manufacturer Country: US
• Manufacturer Postal: 30093
• Manufacturer Phone: 7707170904
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 3.5F BETA-RAIL DELIVERY CATHETER
• Generic Name: CATHETER
• Product Code: MOU
• Date Received: 2005-03-31
• Returned To Mfg: 2004-11-18
• Model Number: P02578
• Catalog Number: ABR-0346
• Lot Number: 712654
• ID Number: NA
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 591986
• Manufacturer: NOVOSTE CORP.
• Manufacturer Address: 4350 INTERNATIONAL BLVD. NORCROSS GA 30093 US
• Baseline Brand Name: 3.5F BETA-RAIL DELIVERY CATHETER
• Baseline Generic Name: CATHETER
• Baseline Model No: P02578
• Baseline Catalog No: ABR-0346
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-31