3.5 BETA-RAIL DELIVERY CATHETER P02561 ABR-0346

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-07-27 for 3.5 BETA-RAIL DELIVERY CATHETER P02561 ABR-0346 manufactured by Novoste Corp..

Event Text Entries

[15216329] During a procedure that included the beta-rail delivery catheter, there was a dissection. Pt death occurred.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1062385-2004-00005
• MDR Report Key: 536598
• Report Source: 07
• Date Received: 2004-07-27
• Date of Report: 2004-07-26
• Date of Event: 2004-07-23
• Date Mfgr Received: 2004-07-23
• Date Added to Maude: 2004-07-30
• 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: ANDREW GREEN, VP/QA
• Manufacturer Street: 3890 STEFE REYNOLDS BLVD.
• Manufacturer City: NORCROSS GA 30093
• Manufacturer Country: US
• Manufacturer Postal: 30093
• Manufacturer Phone: 7707176059
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 3.5 BETA-RAIL DELIVERY CATHETER
• Generic Name: CATHETER
• Product Code: MOU
• Date Received: 2004-07-27
• Model Number: P02561
• Catalog Number: ABR-0346
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 525847
• Manufacturer: NOVOSTE CORP.
• Manufacturer Address: 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US
• Baseline Brand Name: 3.5 BETA-RAIL DELIVERY CATHETER
• Baseline Generic Name: CATHETER
• Baseline Model No: P02561
• Baseline Catalog No: ABR-0346
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-07-27