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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 05/18/2020
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 used during cases with dissections, but the devices had already been discarded. The physician also stated the events were not reported to csi prior to publication of the article because, "we do not consider this as usae to report. " 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. Known inherent risk of device: 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. Shammas, n. W. , shammas, w. J. , jones-miller, s. , torey, j. T. , armstrong, e. J. , radaideh, q. , & shammas, g. A. (2020, may 18). Optimal vessel sizing and understanding dissections in infrapopliteal interventions: data from the idissection below the knee study. Journal of endovascular therapy, 27(4), 575-580. Doi:https://doi. Org/10. 1177/1526602820924815. Csi id: (b)(4).
 
Event Description
Shammas 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, dissections occurred. Specifically, the article states there were, "12 dissections after oa (8 intima, 1 media, 3 adventitia), and 11 dissections following oa+pta (7 intima, 1 media, 3 adventitia; p
=
0. 425 vs pta). " the article also states, "bailout stenting (all due to angiographic dissections greater than or equal to c) was necessary in. None of the oa+pta group. ".
 
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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 Key11097887
MDR Text Key224596371
Report Number3004742232-2020-00405
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 Received05/22/2020
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: 12/30/2020 Patient Sequence Number: 1
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