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

Model Number	PRD-SC30-MICRO
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
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.The viperwire guide wire referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that a stealth 360 peripheral orbital atherectomy device (oad) was used for treatment of 99% stenosed mid anterior tibial artery (at).The vessel was small and tortuous.The oad became stuck on the viperwire advance guide wire in the vessel.The procedure was aborted and the oad and viperwire were removed together.The procedure was aborted due to patient anatomy and the oad unable to be separated from viperwire.The patient was brought back two days later for plain old balloon angioplasty (poba) on the same vessel which was unsuccessful.The patient was transferred to a hospital that day for amputation where below-the-knee amputation was performed the same day.The patient was discharged from the hospital three days later.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported difficulty to remove from the guide wire and the anatomy, delay to treatment and hospitalization appear to be related to operational context.In this case, it is possible that the reported difficulty to remove from the guide wire and the anatomy, delay to treatment and hospitalization are related to the patient disease severity and/or use techniques employed.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: g3, g6, h2, h6.H6: codes 4118, 3233, and 11 no longer apply.H10: the viperwire guide wire referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that a stealth 360 peripheral orbital atherectomy device (oad) was used for treatment of 99% stenosed mid anterior tibial artery (at).The vessel was small and tortuous.The oad became stuck on the viperwire advance guide wire in the vessel.The procedure was aborted and the oad and viperwire were removed together.The procedure was aborted due to patient anatomy and the oad unable to be separated from viperwire.The patient was brought back two days later for plain old balloon angioplasty (poba) on the same vessel which was unsuccessful.The patient was transferred to a hospital that day for amputation where below-the-knee amputation was performed the same day.The patient was discharged from the hospital three days later.

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 23211033
• Report Number: 3004742232-2025-00292
• Device Sequence Number: 9159280
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)270228(10)566255-1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/06/2025

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-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 566255-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female