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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-MICRO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 02/08/2021
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. Csi id# (b)(4).
 
Event Description
A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a 100% stenosed lesion with high grade calcium in the posterior tibial artery. The vessel was 2. 5mm in diameter with no tortuosity. When the oad was removed after orbital atherectomy, tissue was observed on the crown. A type d dissection was observed via angiography. Prolonged percutaneous transluminal angioplasty and an unplanned stent placement were performed to treat the dissection. The patient was stable following the procedure.
 
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Brand NameSTEALTH 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 Key11343366
MDR Text Key232377061
Report Number3004742232-2021-00049
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10850000491264
UDI-Public(01)10850000491264(17)220831(10)342739
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2022
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Device Lot Number342739
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 Received02/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2020
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: 02/18/2021 Patient Sequence Number: 1
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