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

Model Number	RAD-SC30-150
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was returned with the guide wire engaged and stuck.Review of the device data log identified a stall event during the procedure.Analysis of the fractured driveshaf filars found evidence that the oad was spun under an elevated stress condition resulting in the damage.The root cause of the fracture 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).
Event or Problem Description
The stealth 360 peripheral orbital atherectomy device (oad) was used for treatment in the common femoral.The oad was spun on low speed and medium speed without issue.While spinning the oad on high speed, the oad stalled and became stuck on the viperwire advance guide wire.Both the oad and viperwire were removed together.The vessel was rewired with a non-abbott guidewire and angioplasty was performed to complete the procedure.The patient was stable.Additional information was received during device analysis that indicated the driveshaft fractured.

• Brand Name: STEALTH
• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 20256082
• Report Number: 3004742232-2024-00328
• Device Sequence Number: 7987723
• Product Code: MCW
• UDI-Device Identifier: 10850000491318
• UDI-Public: (01)10850000491318(17)260131(10)523528-1
• 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): 09/19/2024

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: 01/31/2026
• Device Model Number: RAD-SC30-150
• Device Catalogue Number: 7-10059-06
• Device Lot Number: 523528-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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