BETA CATH 3.5 FR, 40 MM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-01 for BETA CATH 3.5 FR, 40 MM * manufactured by Novoste.

Event Text Entries

[312789] Failure to retract radioactive source train. Pt was undergoing intravascular brachytherapy of coronary artery for prevention of restenosis. Artery was kinked distal to treatment site. Physicians noted some difficulty in advancing source train into treatment site. Extra force on syringe plunger was required to move source train past kink. At completion of therapy the physician attempted to retract source train using normal mfr's procedure (inject fluid into retrieval channel). Source train would not retract. Physician removed entire catheter from pt manually. During removal a second attempt was made to retract source train using normal procedure. Source train still could not be retracted. No anticipated negative impact on pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033343
• MDR Report Key: 557475
• Date Received: 2004-10-04
• Date of Report: 2004-10-01
• Date of Event: 2004-09-29
• Date Added to Maude: 2004-12-06
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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: BETA CATH
• Generic Name: INTRAVASCULAR BRACHYTHERAPY TREATMENT
• Product Code: MOU
• Date Received: 2004-10-01
• Model Number: 3.5 FR, 40 MM
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2004-12-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 547143
• Manufacturer: NOVOSTE
• Manufacturer Address: * NORCROSS GA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-10-04