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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-150
Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)
Patient Problem Vascular Dissection (3160)
Event Date 01/17/2020
Event Type  Injury  
Manufacturer Narrative
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(4).
 
Event Description
During a procedure, the diamondback peripheral orbital atherectomy device (oad) was advanced to the target, 70% stenosed lesion located in an area of the peroneal artery that was approximately 3 millimeters in diameter. The target lesion varied between mild and severe calcification and was accessed via a femoral approach. The oad stopped spinning as soon as it was turned on, and there were no led lights lit on the oad handle. Troubleshooting was attempted, but the issue recurred. In the physician's opinion, the oad and guide wire were not subintimal and the guide wire was not kinked. The oad was removed from the patient, and briefly became stuck during removal, however, it then was removed smoothly. A possible piece of intima was observed on the crown of the oad. Imaging was performed, and a type c dissection was present in the peroneal artery. Balloon angioplasty, which had been originally scheduled, was then performed in the peroneal artery. A second oad was used to treat another lesion in the superficial femoral artery (sfa) successfully. There were no additional patient complications reported.
 
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Brand NameSTEALTH 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
sarah hicks
1225 old highway 8 nw
saint paul, mn 
MDR Report Key9701356
MDR Text Key188661210
Report Number3004742232-2020-00037
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 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRD-SC30-150
Device Catalogue Number70056-04
Device Lot Number301869
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2019
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: 02/12/2020 Patient Sequence Number: 1
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