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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-SC30-125
Device Problem Entrapment of Device (1212)
Patient Problem Vascular Dissection (3160)
Event Date 04/07/2021
Event Type  Injury  
Manufacturer Narrative
The reported oad and guide wire were received for analysis. No damage was observed on the oad. The spring tip of the guide wire was deformed but remained intact. The guide wire passed through the oad driveshaft and handle assembly with no resistance. The oad was tested, spun on all speeds, and functioned as intended. The device data log did not reveal any issues that would have contributed to the reported event. At the conclusion of the device analysis, the reported event was unable to be conclusively confirmed. 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 peripheral stealth orbital atherectomy device and viperwire guide wire were selected for treatment of a lesion in the distal posterior tibial artery. After six treatments, the oad was stuck on the guide wire, and a dissection was observed. The dissection was treated with an unplanned balloon angioplasty for three minutes. The procedure was then completed, and the patient was discharged home.
 
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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 Key11776892
MDR Text Key249042223
Report Number3004742232-2021-00165
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
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRD-SC30-125
Device Catalogue Number7-10059-02
Device Lot Number353214-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2021
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: 05/05/2021 Patient Sequence Number: 1
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