BETA-CATH SYSTEM A1732 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-31 for BETA-CATH SYSTEM A1732 * manufactured by Novoste Corp.

Event Text Entries

[247248] Complainant reported late stent thrombosis in a brachytherapy pt with no new stent. A six-month-old restenosed stent was radiated using the beta-cath system. Because of a gastro-intestinal bleed, asa and plavix were discontinued at an outside hosp. Two weeks later the pt thrombosed and had to be given primary angioplasty. Pt had to be given primary angioplasty to treat the thrombus formation. Pt recovered. Current product instructions for use specify "antiplatelet therapy recommendations" in "section iii. Essential prescribing information". Additionally, clinical results supporting the need for antiplatelet therapy are also included in the product instructions for use. Pts that cannot be administered antiplatelet and/or anticoagulant therapy due to pre-existing conditions should not be considered for treatment with vascular brachytherapy. The product instructions for use further specify late stent thrombosis and thrombotic occlusions as potential adverse events associated with percutaneous coronary interventions. No further design, mfg, labeling, or therapy changes are proposed at this time. There is no follow-up report anticipated at this time. This is an isolated occurrence. Product should be used in accordance with labeling restrictions. No corrective action is planned at this time. Beta-cath system product instructions for use contain the necessary and appropriate info to successfully treat pts with vascular brachytherapy while minimizing pt and user safety risks. Product complaints will continue to be reviewed on a monthly basis, at a minimum, for similar occurrences or trends of adverse events.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003304
• MDR Report Key: 399418
• Date Received: 2002-05-31
• Date of Report: 2002-05-29
• Date Added to Maude: 2002-06-17
• 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
• 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 Sequence Number: 1

• Brand Name: BETA-CATH SYSTEM
• Generic Name: CORONARY VASCULAR BRACHYTHERAPY SYSTEM
• Product Code: MOV
• Date Received: 2002-05-31
• Model Number: A1732
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 388469
• Manufacturer: NOVOSTE CORP
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: BETA-CATH SYSTEM
• Generic Name: CORONARY VASCULAR BRACHYTHERAPY SYSTEM
• Product Code: MOV
• Date Received: 2002-05-31
• Model Number: *
• Catalog Number: BCK-0130
• Lot Number: UNK
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 388472
• Manufacturer: NOVOSTE CORP
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-05-31