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

Model Number	DBE-150
Medical Device Problem Codes	Break (1069); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
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 during setup the strain relief of the stealth 360 peripheral orbital atherectomy device (oad) separated from the oad.It was unknown what caused the damage.The oad was loaded onto a viperwire advance guide wire that was in vivo at the time of event.Additionally, the oad driveshaft was stretched and the crown broke off in the sheath.The sheath was removed quickly from the patient, along with the crown inside.The oad was replaced to complete the procedure.Manual pressure was applied for hemostasis as no closure device was utilized in the laboratory.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis were performed on the returned device.The reported detached strain relief and crown material separation were confirmed.The reported stretched driveshaft was not 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.Detailed analysis shows the presence of solder at the crown bond location on the driveshaft and the crown internal diameter, indicating that the crown had been bonded to the driveshaft.The cause of the damage remains undetermined, and the detached strain relief appears to be unrelated to the separated crown.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: e1-phone number, g3, g6, h2, h3, h6 (codes 4755, 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported that during setup the strain relief of the stealth 360 peripheral orbital atherectomy device (oad) separated from the oad.It was unknown what caused the damage.The oad was loaded onto a viperwire advance guide wire that was in vivo at the time of event.Additionally, the oad driveshaft was stretched and the crown broke off in the sheath.The sheath was removed quickly from the patient, along with the crown inside.The oad was replaced to complete the procedure.Manual pressure was applied for hemostasis as no closure device was utilized in the laboratory.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 23789748
• Report Number: 3004742232-2025-00373
• Device Sequence Number: 14839372
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)260131(10)522817-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/17/2026

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: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 522817-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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