MAUDE Adverse Event Report: Cardiovascular Systems Incorporated Stealth; Catheter, Peripheral, Atherectomy

Model Number	PRD-SC30-125
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat mildly calcified, mildly tortuous lesion in anterior tibial artery (at) through common femoral artery access.The vessel diameter was unknown as no intravascular ultrasound (ivus) was used.During treatment, the crown of the 1.25 solid stealth 360 peripheral orbital atherectomy device (oad) became stuck at the midpoint of the artery.Additional nitroglycerin beyond standard of care was administered, the oad was turned off/on several times, and the oad was removed from the patient.The oad was intact and had no tissue/plaque.The procedure was completed without using other devices.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; +1(651)756-2718
• MDR Report Key: 50090293
• Report Number: 3004742232-2026-00187
• Device Sequence Number: 16044297
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)280331(10)604939-1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 604939-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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