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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
Model Number DBP-125MICRO60
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 06/09/2020
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. The device history record for this oad lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements. The diamondback peripheral orbital atherectomy system instructions for use manual states that perforation is a potential adverse event, that may occur and/or require intervention. Additional event and patient information has been requested, but has not yet been received. If additional information is received, a supplemental report will be submitted. (b)(4).
 
Event Description
During a procedure with a diamondback peripheral orbital atherectomy device (oad), a vessel perforation occurred, and a subsequent stent was deployed.
 
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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
saint paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS INC.,
1225 old highway 8 nw
saint paul, mn
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, mn 
MDR Report Key10248670
MDR Text Key198090962
Report Number3004742232-2020-00179
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,Followup
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Model NumberDBP-125MICRO60
Device Catalogue NumberDBP-125MICRO60
Device Lot Number298754
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2019
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: 07/08/2020 Patient Sequence Number: 1
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