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

Model Number	DBE-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/12/2026
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.
Event or Problem Description
It was reported a stealth 360 peripheral orbital atherectomy device (oad) was being used to treat lesions in the distal popliteal and proximal peroneal artery.One low speed treatment, followed by two medium speed treatments were performed in the popliteal artery, and two low speed treatments were performed in the peroneal artery.As the physician was removing the oad by bringing the oad control knob back to the start position, the oad got caught in tissue, and possibly wrapped in tissue.The physician was unable to remove the oad.The viperwire guide wire was able to move freely.A new access site in the superficial femoral artery (sfa) and an unspecified balloon were used to help the oad crown get unwedged, however, this was unsuccessful.The physician had to use force to pull the oad out successfully.An esprit stent was placed where the oad crown caused a dissection/removed tissue from the peroneal.No additional information was provided.

• 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: 25355123
• Report Number: 3004742232-2026-00133
• Device Sequence Number: 18805066
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)280228(10)603252-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/05/2026

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: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 603252-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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 Age: 79 YR
• Patient Sex: Male