MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	RAD-SC30-175
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was returned for analysis.There was no damage or abnormalities observed with the driveshaft or handle assembly that could have contributed to the reported event.There was no blood observed within the saline sheath or saline line assembly.Fluid flow testing through the oad and saline sheath did not identify any irregularities.When tested, the oad functioned as intended.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 or Problem Description
A stealth 360 peripheral orbital atherectomy device (oad) was used for six treatments.After the treatments, it was noticed that the amount of viperslide in the bag was not decreasing despite a lot of flushing.Blood was observed in the saline tubing.The treatment was completed with no further issues.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17487856
• Report Number: 3004742232-2023-00201
• Device Sequence Number: 15409242
• Product Code: MCW
• UDI-Device Identifier: 10850000491325
• UDI-Public: (01)10850000491325(17)241130(10)463233-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: RAD-SC30-175
• Device Catalogue Number: 7-10059-07
• Device Lot Number: 463233-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown