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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 DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Vascular Dissection (3160)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
Investigation conclusion: csi contacted the corresponding author of the article and requested model numbers and lot numbers. Csi also requested information regarding possible return of any of the devices. No response was received from the corresponding author. 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. Patient age: the average patient age was (b)(6) years plus or minus 7. 1 years date of article is 4 may 2020; however, csi is aware that the events occurred on or before (b)(6) 2018. The diamondback 360® peripheral orbital atherectomy system instructions for use manual states that dissection 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. Kokkinidis, d. , jawaid, o. , cantu, d. , martinsen, b. , igyarto, z. , valle, j. ,. Armstrong, e. (2020, may 4). Two-year outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of heavily calcified femoropopliteal lesions. Journal of endovascular therapy, 27(3), 492-501. Doi:https://doi. Org/10. 1177/1526602820915244. (b)(4).
 
Event Description
Kokkinidis et al 2020 - a literature article was published in may 2020 which indicated the following: during procedures in which csi peripheral orbital atherectomy devices (oads) were used, eight type a and b dissections occurred, and three type c-f dissections occurred.
 
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Brand NameDIAMONDBACK 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 Key11096893
MDR Text Key225766204
Report Number3004742232-2020-00429
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 Received12/10/2018
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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