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

Model Number	PRD-SC30-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury

• 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: 50825007
• Report Number: 3004742232-2026-00230
• Device Sequence Number: 21382889
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)280430(10)609004-1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K210586
• 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
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 609004-1
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2026
• 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