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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 03/27/2019
Event Type  Injury  
Manufacturer Narrative
Investigation conclusion: csi contacted the corresponding author of the article and requested model numbers and lot numbers, but neither were available. Csi also requested information regarding possible return of any of the devices, but information regarding availability of the devices was not available. If the devices do become available, they will be analyzed. The results of the investigation are inconclusive since the reported devices were not returned for analysis. Based on the information received, the cause of the reported events could not be conclusively determined. The device history record for the reported oad could not be reviewed, as the lot number was not provided. If the lot number is provided, a dhr review will be performed. Date of article is 10 june 2020; however, csi is aware that the events occurred on or before (b)(6) 2019. Known inherent risk of device: the diamondback360® peripheral orbital atherectomy system instructions for use manual states that thrombus is a potential adverse event that may occur with use of the system. Date received by manufacturer - due to an inadvertent delay in notification of the events within the article to postmarket surveillance, the mdr was not sent within 30 days of a csi employee becoming aware. Additional training was provided regarding csi's procedures for reporting complaints to postmarket surveillance. E. Ivan, b. Martinsen, z. Igyarto, et al. , peripheral artery disease in vulnerable patient populations: outcomes of orbital atherectomy in native americans compared to non-native americans. A single center experience in rural oklahoma, cardiovascular revascularization medicine (2020), https://doi. Org/10. 1016/j. Carrev. 2020. 06. 008. Csi id: (b)(4).
 
Event Description
Ivan et al. , 2020 - a literature article was published in june 2020 which indicated the following: during procedures in which csi peripheral orbital atherectomy devices (oads) were used, one instance of thrombus occurred.
 
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Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY SYSTEM
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key11096588
MDR Text Key224858511
Report Number3004742232-2020-00428
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,litera
Reporter Occupation
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/27/2019
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: 12/30/2020 Patient Sequence Number: 1
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