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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number RAD-SC30-175
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 08/15/2019
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. The stealth peripheral orbital atherectomy system instructions for use manual states that dissection is a potential adverse event that may occur and/or require intervention. (b)(4).
 
Event Description
The target lesion was in the superficial femoral artery (sfa) and was 100% stenosed. Six treatment passes were performed with a peripheral stealth radial orbital atherectomy device (oad) on medium and high speeds. Balloon angioplasty dilatation was then performed, however significant residual stenosis remained. A shorter balloon at high pressure was then used to perform dilatation in the mid sfa, following which a type c dissection was noted. The balloon was inflated in place and access was gained to the posterior tibial artery. A sheath was inserted and a stent was delivered. The balloon was then used to dilate the stent. The final angiogram showed excellent flow and the patient was discharged the same day.
 
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Brand NameSTEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul, mn MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul, mn MN 55112
Manufacturer Contact
laramie otto
1225 old highway 8 nw
st. paul, mn, MN 55112
6512591600
MDR Report Key9416286
MDR Text Key169241982
Report Number3004742232-2019-00318
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Model NumberRAD-SC30-175
Device Catalogue Number7-10058-03
Device Lot Number265339
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 Received12/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2019
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: 12/05/2019 Patient Sequence Number: 1
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