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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
Device Problem Unexpected Shutdown (4019)
Patient Problem Vascular Dissection (3160)
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. Additional information regarding this event has been requested. If additional information is received, a supplemental report will be submitted. Csi id: (b)(4).
 
Event Description
Imran et al. , 2018 - a literature article was published in march 2019 which indicated the following: during a peripheral atherectomy procedure using a csi diamondback orbital atherectomy device (oad), the device stopped spinning, which resulted in a superficial femoral artery dissection. The dissection was treated with balloon angioplasty and stent placement. Additional information has been requested but not yet received.
 
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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
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul MN 55112
Manufacturer Contact
laramie otto
1225 old highway 8 nw
st. paul, MN 55112
6512691600
MDR Report Key8625273
MDR Text Key145550186
Report Number3004742232-2019-00141
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/20/2019 Patient Sequence Number: 1
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