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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 No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
The reported oad was received for analysis. The oad driveshaft near the lap weld was overloaded. It was possible the overloaded driveshaft may have been a contributing factor in the reported event, however, the root cause of the damage was unable to be determined. Driveshaft overloading is an indication that the spinning driveshaft met sudden resistance bringing it to a stall condition. No other damage on the driveshaft or handle assembly was observed. Blood was observed within the saline sheath. The fluid accumulation is not considered a contributing factor to the reported event. A guide wire was unable to pass through the overloaded area of the driveshaft. The oad was tested, spun on all speeds and functioned as intended. The control knob was traversed, and the crown moved at a 1:1 ratio with the control knob. The oad was turned on and off numerous times without any issue or popping noise observed. At the conclusion of the device analysis, the reported event of a popping noise and the control knob and crown moving independently was not able 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 stealth orbital atherectomy device (oad) was selected for treatment of a heavily stenosed lesion in the common femoral artery (cfa) via brachial access. The oad was positioned using significant force, and as the oad engaged the lesion, a popping sound was heard. The oad was turned off, and it was noted that the control knob and crown were not moving at a 1:1 ratio. The oad and guide wire were removed, and the crown was observed to move independently of the control knob. The lesion was difficult to rewire, and the procedure was delayed by greater than 30 minutes. The procedure was completed with balloon angioplasty, and no patient adverse events were reported.
 
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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 Key11046535
MDR Text Key228440371
Report Number3004742232-2020-00415
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 12/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRD-SC30-200
Device Catalogue Number70056-06
Device Lot Number306429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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