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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-MICRO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The diamondback360® peripheral orbital atherectomy system instructions for use manual states that distal embolization is an adverse event that can occur during use of the device. The device history record for the reported oad was unable to be reviewed, as the lot number was not provided. (b)(4).
 
Event Description
The stealth peripheral orbital atherectomy device (oad) was operated on low, medium and high speeds for one treatment pass each, in a calcified tibioperoneal trunk artery. It is believed that damage to the intima occurred, as intima debris was noted to travel distally to the foot. Balloon angioplasty was performed to push the debris into a nearby collateral vessel. The area of the vessel wall where suspected intima damage occurred did not require additional intervention. Upon removal, tissue was observed on the crown of the oad. The patient was in stable condition.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, mn 
2591600
MDR Report Key9749610
MDR Text Key180725900
Report Number3004742232-2020-00054
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2020 Patient Sequence Number: 1
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