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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL; CATHETER, PERIPHERAL, ATHERECTOMY
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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number DBP-125MICRO145
Device Problem Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2020
Event Type  malfunction  
Event Description
Focal significant stenosis of the p3 segment of the popliteal artery and occlusion of all tibial arteries.Successful atherectomy and pta of the entire anterior tibial artery and popliteal arteries using right pedal access and antegrade sfa access.Completion angiogram demonstrates widely patent anterior tibial artery and popliteal arteries with focal moderate stenosis of the dorsalis pedis artery.Patent plantar arch.With the last pass of the device the physician attempted to turn the device off which was unsuccessful, the tech disconnected the device from the power source which then turned the device off and the device could be removed safely.
 
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Brand Name
DIAMONDBACK PERIPHERAL
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul MN 55112
MDR Report Key10275567
MDR Text Key198897024
Report Number10275567
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10850000491172
UDI-Public(01)10850000491172(17)220331(10)317292
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDBP-125MICRO145
Device Catalogue Number7-10057-01
Device Lot Number317292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2020
Event Location Hospital
Date Report to Manufacturer07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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