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

Model Number	PRD-SC30-125
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	12/18/2024
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 the stealth 360 peripheral orbital atherectomy device (oad) was used in a tight area of heavily calcified and heavily tortuous proximal segment of the anterior tibial (at) artery, when the oad shut off during second treatment.The lights on the oad were still on when it stopped spinning.It was initially suspected that the oad was stuck but it was able to be removed without any issues.It was noted the saline pump did not power off when the issue occurred.Angiography was performed and pseudoaneurysm was observed.A covered stent was placed to complete the procedure.The patient was in stable condition.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis were performed on the returned device.The reported compliant of unexpected shutdown was confirmed.The reported complaints of pseudoaneurysm and related medical intervention were not able to be confirmed due to the operational context of the reported issue.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, a definitive cause for the reported unexpected shutdown pseudoaneurysm and related medical intervention could not be determined.Detailed analysis of the orbital atherectomy device (oad) confirmed that the device experienced a stall event during the second treatment spin after 17 seconds.It is unknown if the device stall event and the patient injury are related.Analysis also found the crown to be dislocated from the solder bond location but still engaged on the driveshaft.It is possible that the crown experienced high friction during spinning which allowed solder to reflow and crown displacement.This is consistent with complaint details which state that the oad was used in a tight area of heavily calcified and heavily tortuous proximal segment of the anterior tibial (at) artery; although, the exact cause of the separation is unknown.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.Updated fields: d9, g3, g6, h2, h3, h6 (component code, type of investigation, investigation findings, investigation conclusions).Corrected fields: b5 - updated verbiage.
Event or Problem Description
It was reported the stealth 360 peripheral orbital atherectomy device (oad) was used in a tight area of heavily calcified and heavily tortuous proximal segment of the anterior tibial (at) artery, when the oad shut off during second treatment.The lights on the oad were still on when it stopped spinning.The oad was removed without any issues.It was noted the saline pump did not power off when the issue occurred.Angiography was performed and pseudoaneurysm was observed.A covered stent was placed to complete the procedure.The patient was in stable condition.

• 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: 21116459
• Report Number: 3004742232-2025-00012
• Device Sequence Number: 12665169
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)260630(10)542338-1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/21/2025

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 Expiration Date: 06/30/2026
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: PRD-SC30-125
• Device Lot Number: 542338-1
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White