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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK EXCHANGEABLE SERIES PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number EX-150SOL145
Device Problem Off-Label Use (1494)
Patient Problem Vascular Dissection (3160)
Event Date 06/04/2021
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis. 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. Based on the information received, the cause of the reported event could not be conclusively determined. However, the cause was traced to user error and intentional off-label use of the device since the operator did not follow guidance outlined in the diamondback 360® peripheral orbital atherectomy system exchangeable series instructions for use manual, which states, ". Maintain a travel rate between 1 mm per second and 10 mm per second. " csi id: (b)(4).
 
Event Description
Despite guidance from csi field staff, the user of the diamondback exchangeable series orbital atherectomy device (oad) performed treatment at approximately 15cm per second in the superficial femoral artery. A 100cm spiral dissection occurred as a result of the failure to follow the instructions for use, which were repeatedly verbally provided to the user by field staff. A covered stent was placed to treat the dissection, and the patient was stable.
 
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Brand NameDIAMONDBACK EXCHANGEABLE SERIES PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
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 Key12075567
MDR Text Key258641625
Report Number3004742232-2021-00238
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 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEX-150SOL145
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 Received06/04/2021
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: 06/28/2021 Patient Sequence Number: 1
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