DIAMONDBACK PERIPHERAL DBP-200SOLID145 7-10057-04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for DIAMONDBACK PERIPHERAL DBP-200SOLID145 7-10057-04 manufactured by Cardiovascular Systems, Inc..

Event Text Entries

[183517378] From staff: surgeon went to perform coronary stent implantation atherectomy on right leg; circulating rn passed coronary stent implantation device to surgeon following sterile guidelines. Coronary stent implantation machine was primed and inserted into right leg and used. Surgeon stated that the machine wasn't working properly, however did not know exactly what wasn't working properly. Team switched out coronary stent implantation device and had no other problems with atherectomy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9835001
MDR Report Key9835001
Date Received2020-03-16
Date of Report2020-03-04
Date of Event2020-02-26
Report Date2020-03-04
Date Reported to FDA2020-03-04
Date Reported to Mfgr2020-03-16
Date Added to Maude2020-03-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIAMONDBACK PERIPHERAL
Generic NameCATHETER, PERIPHERAL, ATHERECTOMY
Product CodeMCW
Date Received2020-03-16
Model NumberDBP-200SOLID145
Catalog Number7-10057-04
Lot Number266811
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDIOVASCULAR SYSTEMS, INC.
Manufacturer Address1225 OLD HIGHWAY 8 NW SAINT PAUL MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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