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

Model Number	PRD-MAX-200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A stealth 360 peripheral orbital atherectomy device (oad) was being used to treat a severely calcified lesion in the right common femoral artery.As the oad was advanced, a high pitch noise was heard and the oad stopped advancing through the lesion.The oad was attempted to be advanced three times before the physician stopped the procedure to evaluate the oad.The saline sheath appeared to be separated, but not detached.A new oad was used to complete the procedure.The patient was in stable condition.
Additional Manufacturer Narrative
The oad was returned to csi for analysis.The saline sheath and driveshaft were observed to be fractured.Stall events were identified in the device data log.Scanning electron microscopy identified evidence of fatigue indicating that the device likely spun in a high-stress environment.The compressive force may have been applied to the device causing the reported fractures.However, the root cause of the event could not be conclusively 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 PERIPHERAL ORIBITAL ATHERECTOMY DEVICE
• Common Device Name: PERIPHERAL ORBITAL 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: sadie martin ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16973892
• Report Number: 3004742232-2023-00134
• Device Sequence Number: 19443463
• Product Code: MCW
• UDI-Device Identifier: 10850026568711
• UDI-Public: (01)10850026568711(17)241231(10)467019-1
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: 12/31/2024
• Device Model Number: PRD-MAX-200
• Device Catalogue Number: 7-10059-46
• Device Lot Number: 467019-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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: Male
• Patient Race: White