DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 70058-13

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 DBEC-125 70058-13 manufactured by Cardiovascular Systems, Inc..

MAUDE Entry Details

Report Number3004742232-2020-00098
MDR Report Key9908589
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-11-26
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 ContactBRITTANY LEIDER
Manufacturer Street1225 OLD HIGHWAY 8 NW
Manufacturer CitySAINT PAUL, MN
Manufacturer CountryUS
Manufacturer Phone2591600
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 NumberDBEC-125
Catalog Number70058-13
Lot Number300319
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
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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