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

Model Number	PRD-SC30-200
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a stealth 360 peripheral orbital atherectomy device (oad) was used for three total treatments on medium and high speed on a proximal peroneal artery.It was indicated tissue got wrapped on the oad and clots formed distal to the treatment area post orbital atherectomy treatment.There were no abnormal device symptoms or behaviors prior to the adverse event.The patient was appropriately heparinized in preparation for the procedure.Prolonged anticoagulation medication and thrombolytics were administered.The patient had a distal emboli at the end of the procedure.The patient was discharged in stable condition.
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 a stealth 360 peripheral orbital atherectomy device (oad) was used for three total treatments on medium and high speed on a proximal peroneal artery.It was indicated tissue got wrapped on the oad and clots formed distal to the treatment area post orbital atherectomy treatment.There were no abnormal device symptoms or behaviors prior to the adverse event.The patient was appropriately heparinized in preparation for the procedure.Prolonged anticoagulation medication and thrombolytics were administered.The patient had a distal emboli at the end of the procedure.The patient was discharged.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis, and detailed analysis were performed on the returned device.The reported device contaminated at the user facility was confirmed.The reported patient effects could not be confirmed due to the operational context of the reported issues.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, the investigation determined that the reported device contaminated at the user facility appears to be related to circumstances of the procedure.During analysis, a test wire would not pass the driveshaft crown section due to biological material accumulation.There was no damage or abnormalities identified that would have contributed to the material accumulation.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: h6 (codes 4755, 4118, 3233, and 11 no longer apply).

• 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: 22956599
• Report Number: 3004742232-2025-00257
• Device Sequence Number: 9894161
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)270131(10)563822-1
• Combination Product (Y/N): N
• 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): 10/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 563822-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown