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

Model Number	PRD-SC30-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
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 to treat a mildly calcified, mildly tortuous, 100% stenosed proximal to mid superficial femoral artery (sfa) in the left leg through an up and over approach.One low speed treatment, one medium speed treatment, and one high speed treatment were performed.It was noted a dissection was observed at the proximal sfa post orbital atherectomy.A non-abbott stent was placed at the site of the dissection.The patient was in stable condition.
Event or Problem Description
It was reported a stealth 360 peripheral orbital atherectomy device (oad) was used to treat a mildly calcified, mildly tortuous, 100% stenosed proximal to mid superficial femoral artery (sfa) in the left leg through an up and over approach.One low speed treatment, one medium speed treatment, and one high speed treatment were performed.It was noted a dissection was observed at the proximal sfa post orbital atherectomy.A non-abbott stent was placed at the site of the dissection.The patient was in stable condition.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis was performed on the returned device.The reported compliant of vascular dissection could not be confirmed through analysis due to the operational context of the issue.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 vascular dissection appears to be related to circumstances of the procedure.There was no damage or abnormalities identified with the driveshaft or crown section that would have contributed to the reported complaint.There was, however, biological material accumulated on the driveshaft crown section.The biological material accumulation may be related to the reported compliant; however, this is not confirmed, and the cause remains unknown.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.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: 21504467
• Report Number: 3004742232-2025-00045
• Device Sequence Number: 7974586
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)251130(10)516344-1
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 516344-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown