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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-SC30-200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/28/2020
Event Type  Injury  
Manufacturer Narrative
The reported oad was received at csi for analysis. Visual examination did not reveal any damage. When tested for functionality, the oad spun on all speeds as expected. The oad was powered on and off numerous times, without any issues observed. At the conclusion of the device analysis investigation, the report that a vessel spasm occurred, followed by the no flow and slow flow events and embolization of particulate could not be confirmed through analysis. The oad functioned as intended without any issues observed. 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. Dr. (b)(6) is an additional physician participating in this procedure. (b)(4).
 
Event Description
A stealth peripheral orbital atherectomy device was used to treat the superficial femoral artery (sfa). After the sixth treatment pass on low speed, a vessel spasm occurred. No flow was observed in the proximal sfa, and slow flow was observed in the distal sfa and below the knee. Balloons were used in the trifurcation, posterior tibial and anterior tibial arteries to restore flow. The patient condition was stable. Per the opinion of the physician, the no/slow flow event was caused by particulate after orbital atherectomy.
 
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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
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key10897845
MDR Text Key218246976
Report Number3004742232-2020-00378
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
P130005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2022
Device Model NumberPRD-SC30-200
Device Lot Number280677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2019
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: 11/24/2020 Patient Sequence Number: 1
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