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

Model Number	PRD-SC30-150
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The stealth 360 peripheral orbital atherectomy device (oad) was attempted to be used to treat a lower-extremity lesion through left common femoral access but could not be advanced up and over.The physician switched to pedal, anterior tibial access with a 5 x 6 slender guiding sheath.The oad was able to be advanced and the procedure was completed.During removal of the oad while being flushed with saline to aid with the removal, it was noticed that there was a saline leak near the distal end of the oad in-body section / saline sheath, about 6 inches from the crown.The flow of saline to the tip of the oad was considered sufficient enough to avoid injury to the patient.The procedure was completed with no complications.The patient was in stable condition.Additional information was received from the abbott sales representative on 03 january 2025 indicating the oad saline sheath appeared to be punctured when removed from patient.
Additional Manufacturer Narrative
A visual inspection, functional testing and dimensional analysis were performed on the returned device.The reported leak in the saline sheath was confirmed during analysis.Production records 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, a definitive cause for the reported issue could not be determined.Analysis identified a small cut like hole in the distal saline sheath.In this case, it is possible that the damage occurred due to handling during device set up or due to use techniques employed; however this is not confirmed.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, #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: 21241940
• Report Number: 3004742232-2025-00023
• Device Sequence Number: 18280652
• Product Code: MCW
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)260228(10)527987-1
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: 02/28/2026
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: PRD-SC30-150
• Device Lot Number: 527987-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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 Sex: Male