DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM GWC-12325LG-FT 7-10038-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM GWC-12325LG-FT 7-10038-01 manufactured by Cardiovascular Systems, Inc..

MAUDE Entry Details

Report Number3004742232-2020-00096
MDR Report Key9904615
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARAH HICKS
Manufacturer Street1225 OLD HIGHWAY 8 NW
Manufacturer CitySAINT PAUL, MN
Manufacturer CountryUS
Manufacturer G1CARDIOVASCULAR SYSTEMS, INC.
Manufacturer Street1225 OLD HIGHWAY 8 NW
Manufacturer CitySAINT PAUL, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Generic NameCORONARY ATHERECTOMY DEVICE
Product CodeMCX
Date Received2020-03-31
Model NumberGWC-12325LG-FT
Catalog Number7-10038-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARDIOVASCULAR SYSTEMS, INC.
Manufacturer Address1225 OLD HIGHWAY 8 NW SAINT PAUL, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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