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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 Entrapment of Device (1212)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Vascular Dissection (3160)
Event Date 07/30/2020
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 prior to distribution. (b)(4).
 
Event Description
During use of a diamondback peripheral orbital atherectomy device (oad) in the anterior tibial artery, the device interacted with tissue will spinning and became stuck to the vessel wall. The oad was turned off and on multiple times to release the crown, and was removed from the patient. Tissue was noted around the device crown and per the opinion of the physician, a non-visible dissection may have been present prior to the procedure which resulted in the issue. A type b dissection was present following removal of the oad and was resolved with a long balloon inflation. The vessel was then re-wired and another oad was used to complete the procedure. The patient was stable following the procedure.
 
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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
st. paul, mn, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul, mn, mn
Manufacturer Contact
laramie otto
1225 old highway 8 nw
st. paul, mn, mn 
2591600
MDR Report Key10442045
MDR Text Key204003022
Report Number3004742232-2020-00256
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberDBP-125MICRO145
Device Catalogue Number7-10057-01
Device Lot Number309977
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 Received07/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2020
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: 08/24/2020 Patient Sequence Number: 1
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