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	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stealth 360 peripheral orbital atherectomy device (oad) was used for treatment of calcified, non-tortuous, 50-70% stenosed, 3.0mm lesion in distal anterior tibial artery (at) through femoral artery access.There was a pre-existing stent proximal to at that was not treated with oad.A low-speed treatment was successfully performed.During the second low-speed treatment the oad became stuck in the artery.The oad also became stuck on the viperwire advance peripheral guide wire.The oad and viperwire were removed together by pulling with force.As the physician did not want to continue with another oad, the procedure was deemed complete.There were no adverse patient effects and no clinically significant delay in the procedure.The physician had no indication as to what caused the oad to become stuck in the vessel.Device analysis on 26august2025 identified the distal driveshaft crown was engaged in a stent.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis, and detailed analysis were performed on the returned device.The reported device stuck on the guide wire and stuck in vessel are 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 device stuck on the guide wire and stuck in vessel appear to be related to user error.Analysis of the device found a stent wrapped around the distal driveshaft and guide wire exiting the driveshaft.Also, detailed analysis of the device showed that there were multiple speed deceleration and stall events during the procedure.This is likely related to spinning in the stent and becoming stuck.The stealth peripheral oad instruction for use (ifu), in the contraindications section, states: use of the oas is contraindicated for use in the following situations: the target lesion is within a bypass graft or stent.¿ 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.

• 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 ; 6517562718
• MDR Report Key: 23088316
• Report Number: 3004742232-2025-00276
• Device Sequence Number: 10508891
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)270331(10)568249-1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 568249-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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
• Patient Sex: Unknown