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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-125MICRO145
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/08/2020
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. (b)(4). The diamondback peripheral orbital atherectomy device instructions for use states that distal embolization is a possible adverse event which can occur with use of the diamondback peripheral orbital atherectomy device. Csi id# (b)(4).
 
Event Description
The diamondback peripheral orbital atherectomy device (oad) was selected for treatment of lesions in the posterior tibial artery. Treatments were performed on medium and high speeds in the proximal vessel and low and medium in the mid and distal vessel. After spinning, no flow was observed in the distal vessel. It was determined that the no flow was caused by emboli and that orbital atherectomy contributed to the embolization. The type of emboli was undetermined. The vessel was treated with balloon angioplasty, however, flow was unable to be restored. The patient was stable following the procedure. As of (b)(6) 2020, no additional intervention had been performed to restore flow.
 
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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 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key10754534
MDR Text Key213672039
Report Number3004742232-2020-00343
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10850000491172
UDI-Public(01)10850000491172(17)220531(10)326668
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 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Model NumberDBP-125MICRO145
Device Catalogue Number7-10057-01
Device Lot Number326668
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 Received10/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2020
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: 10/29/2020 Patient Sequence Number: 1
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