MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	PRD-SC30-125
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that a stealth 360 peripheral orbital atherectomy device (oad) was being used to treat a moderately calcified proximal segment in the left anterior tibial (at) artery.The flow of saline appeared to be sufficiently flowing during device preparation, however, when it was removed from the body and flushed, it appeared that the saline did not come out of the tip of the oad.During the procedure, it appeared the saline could not reach the handle of the oad, thus the oad was removed from the patient.It was observed blood had backed up into the oad.A second oad was used to complete the procedure.No patient complications were reported as a result of this event.The patient was in stable condition.
Additional Manufacturer Narrative
Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported insufficient flow or under infusion could not be determined.Analysis of the returned saline line identified a piece of foreign material occluding the flow of saline through the tubing.The source of the material could not be conclusively determined, however the appearance is similar to the seal present on saline bags or iv bags that get punctured during a draw.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Updated fields: d9, g3, g6, h2, h3, h6 (component code, type of investigation, investigation findings and investigation conclusions).
Event or Problem Description
It was reported that a stealth 360 peripheral orbital atherectomy device (oad) was being used to treat a moderately calcified proximal segment in the left anterior tibial (at) artery.The flow of saline appeared to be sufficiently flowing during device preparation, however, when it was removed from the body and flushed, it appeared that the saline did not come out of the tip of the oad.During the procedure, it appeared the saline could not reach the handle of the oad, thus the oad was removed from the patient.It was observed blood had backed up into the oad.A second oad was used to complete the procedure.No patient complications were reported as a result of this event.The patient was in stable condition.

• Brand Name: STEALTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 21115906
• Report Number: 3004742232-2025-00010
• Device Sequence Number: 15373398
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)260630(10)541656-1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• 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,Followup
• Report Date (Section B): 02/21/2025

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: 06/30/2026
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: PRD-SC30-125
• Device Lot Number: 541656-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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