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

Model Number	PRD-SC30-200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A stealth 360 peripheral orbital atherectomy device (oad) was used to treat a severely calcified superficial femoral artery.During oad removal, it was observed that the driveshaft fractured.An attempt was made to retrieve the fractured driveshaft, however, the fractured component was pushed further into the lower leg.Additional surgery was performed to remove the component.The patient was stable.
Additional Manufacturer Narrative
The oad was returned to csi.The driveshaft was fractured at the distal edge of the crown.Scanning electron microscopy analysis of the fracture faces was unable to identify the fracture mode due to mechanical polishing of the filars post fracture.Review of the device data log identified stall events at the beginning of the procedure followed by treatment spinning.It is unknown of the stall events were related to the driveshaft fracture.The root cause of the driveshaft fracture was unable to be 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.Csi id: (b)(4).

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17509535
• Report Number: 3004742232-2023-00203
• Device Sequence Number: 20419068
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)250430(10)484261-1
• 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): 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 484261-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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