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

Model Number	PRD-SC30-150
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to treat moderate to severely calcified lesion (5 mm in diameter and 120 mm in length) in the proximal and distal superficial femoral artery (sfa), a stealth peripheral orbital atherectomy device (oad) was initially spun in in the proximal lesion successfully.It was repositioned to the distal lesion and was spun on low and medium speed.The oad seemed to torque down and stopped when it was spun on high speed at the area of patella.The oad could not turn on again.There was difficulty during removal of the oad over the guidewire.The oad and the guidewire were removed together.When the oad was removed out of the sheath, it was noted that the driveshaft of the catheter was fractured and it was believed to be the cause of the issues during removal.It was further noted that the area of the fracture was where the shaft of oad went up and over the iliac bifurcation and was, therefore, inside the sheath.The physician rewired and the procedure was completed without any complications.The patient was in stable condition.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis was performed on the returned device.The reported complaints of unexpected shutdown, difficult to remove, material separation 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 unexpected shutdown, difficult to remove, material separation appears to be related to user error.The orbital atherectomy was returned engaged and stuck on a non-viperwire guide wire.There are fractured driveshaft filars protruding from the saline sheath.Detailed analysis of the fracture shows evidence of fatigue, indicating that the fracture occurred while spinning in a high stress environment.It is likely that spinning on the non-viperwire guide wire contributed to the driveshaft fracture, resulting in the unexpected shutdown and difficult to remove.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.
Event or Problem Description
It was reported that during a procedure to treat moderate to severely calcified lesion (5 mm in diameter and 120 mm in length) in the proximal and distal superficial femoral artery (sfa), a stealth peripheral orbital atherectomy device (oad) was initially spun in in the proximal lesion successfully.It was repositioned to the distal lesion and was spun on low and medium speed.The oad seemed to torque down and stopped when it was spun on high speed at the area of patella.The oad could not turn on again.There was difficulty during removal of the oad over the guidewire.The oad and the guidewire were removed together.When the oad was removed out of the sheath, it was noted that the driveshaft of the catheter was fractured and it was believed to be the cause of the issues during removal.It was further noted that the area of the fracture was where the shaft of oad went up and over the iliac bifurcation and was therefore inside the sheath.The physician rewired and the procedure was completed without any complications.The patient was in stable condition.Additional information received indicated that the physician was aware that the use of oad with a guidewire that is not viperwire is inconsistent with the instructions for use (ifu).

• 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, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 21082861
• Report Number: 3004742232-2025-00008
• Device Sequence Number: 8428133
• Product Code: MCW
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)260430(10)536787-1
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 03/05/2025

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 Expiration Date: 04/30/2026
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: PRD-SC30-150
• Device Lot Number: 536787-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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 Age: 55 YR
• Patient Sex: Male