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

Model Number	DBE-150
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
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 the crown of the stealth 360 peripheral orbital atherectomy device (oad) was not moving relative to the oad driveshaft during treatment of lesion in peroneal artery through femoral ipsilateral approach.The lesion was calcified and 100% stenosed.It was observed the crown had come off of the driveshaft which remained intact.Following planned percutaneous transluminal angioplasty with an unspecified balloon, the detached crown was found on the balloon upon balloon removal from patient.The oad was replaced to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis and detailed analysis was performed on the returned device.The reported complaint of driveshaft fracture was confirmed.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 crown separation appears to be related to circumstances of the procedure.Scanning electron microscope (sem) analysis shows the presence of solder across the crown bond location on the driveshaft and the crown internal diameter, indicating that the crown had been bonded to the driveshaft.Engineering review of the device data log identified a stall event during the procedure.It is possible that the stall event is related to the crown detachment; however, this could not be confirmed.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.
Event or Problem Description
It was reported that the crown of the stealth 360 peripheral orbital atherectomy device (oad) was not moving relative to the oad driveshaft during treatment of lesion in peroneal artery through femoral ipsilateral approach.The lesion was calcified and 100% stenosed.It was observed the crown had come off of the driveshaft which remained intact.Following planned percutaneous transluminal angioplasty with an unspecified balloon, the detached crown was found on the balloon upon balloon removal from patient.The oad was replaced to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information was received indicating the lesion was a chronic total occlusion (cto).The oad was replaced to continue treatment but the crown of the second oad was again observed to be not moving during treatment.

• 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: 21841760
• Report Number: 3004742232-2025-00085
• Device Sequence Number: 7711308
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)260430(10)534651-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/11/2025

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: 04/30/2026
• Device Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 534651-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American