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 NumberMW4003304
MDR Report Key399418
Date Received2002-05-31
Date of Report2002-05-29
Date Added to Maude2002-06-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameBETA-CATH SYSTEM
Generic NameCORONARY VASCULAR BRACHYTHERAPY SYSTEM
Product CodeMOV
Date Received2002-05-31
Model NumberA1732
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key388469
ManufacturerNOVOSTE CORP
Manufacturer Address* * *

Device Sequence Number: 2

Brand NameBETA-CATH SYSTEM
Generic NameCORONARY VASCULAR BRACHYTHERAPY SYSTEM
Product CodeMOV
Date Received2002-05-31
Model Number*
Catalog NumberBCK-0130
Lot NumberUNK
ID Number*
Device Availability*
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key388472
ManufacturerNOVOSTE CORP
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2002-05-31

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