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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ORBITAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-MICRO
Device Problem Entrapment of Device (1212)
Patient Problem Vascular Dissection (3160)
Event Date 09/24/2021
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. Per the physician, it was unknown what the cause of the dissection was. (b)(4).
 
Event Description
The stealth peripheral orbital atherectomy device (oad) was operated in the distal anterior tibial (at) artery, and balloon angioplasty was performed. During removal of the oad, the device became stuck in the distal at. The device was eventually removed after it was activated on low speed. Balloon angioplasty was performed, and treatment to the tibioperoneal trunk and peroneal artery was performed with a second oad. A dissection was observed in the at where the first oad had become stuck in the proximal at. It was unknown when the dissection occurred, and a stent was placed to resolve it. The patient was in stable condition.
 
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Brand NameSTEALTH ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ORBITAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
MDR Report Key12667727
MDR Text Key281529508
Report Number3004742232-2021-00353
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Device Lot Number363313-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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