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

Model Number	PRD-SC30-150
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2025
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 that the 1.5 solid stealth 360 peripheral orbital atherectomy device (oad) was used antegrade to treat lesion in left femoral artery.Following proximal-to-distal treatment, the oad was removed and the last 2 cm of the distal end of the driveshaft past the crown was observed to be fractured and remained in mid superficial femoral artery (sfa).Removal of the fractured component with a balloon and retracting into the sheath was attempted; however, it was unsuccessful.The fractured component was stented to the artery wall in mid sfa.The sfa was patent, with good stent apposition keeping the fragment from migrating and keeping the sfa open.There was no harm done to patient.There are no plans to remove the fragment as it is stented and trapped between the stent and intimal wall of the artery.Trying to retrieve the fragment would do more harm than good.There was no clear indication as to how the fracture occurred, however, the patient was moving a lot during the procedure lifting and lowering their leg, which could have contributed.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis were performed on the returned device.The reported driveshaft fracture is 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 driveshaft fracture appears to be related to circumstances of the procedure.Detailed analysis of the fractured driveshaft showed evidence that the fracture occurred while spinning in an elevated stress condition.The cause of the elevated stress condition 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: g3, g6, h2, h6.Correction: d4.H6: codes 4118, 3233, 11 no longer apply.
Event or Problem Description
It was reported that the 1.5 solid stealth 360 peripheral orbital atherectomy device (oad) was used antegrade to treat lesion in left femoral artery.Following proximal-to-distal treatment, the oad was removed and the last 2 cm of the distal end of the driveshaft past the crown was observed to be fractured and remained in mid superficial femoral artery (sfa).Removal of the fractured component with a balloon and retracting into the sheath was attempted; however, it was unsuccessful.The fractured component was stented to the artery wall in mid sfa.The sfa was patent, with good stent apposition keeping the fragment from migrating and keeping the sfa open.There was no harm done to patient.There are no plans to remove the fragment as it is stented and trapped between the stent and intimal wall of the artery.Trying to retrieve the fragment would do more harm than good.There was no clear indication as to how the fracture occurred, however, the patient was moving a lot during the procedure lifting and lowering their leg, which could have contributed.

• 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: 21921365
• Report Number: 3004742232-2025-00105
• Device Sequence Number: 8715037
• Product Code: MCW
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)260430(10)535454-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 7-10059-03
• Device Lot Number: 535454-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White