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

Model Number	PRD-SC30-200
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 2.0 solid stealth 360 peripheral orbital atherectomy device (oad) was successfully used for treatment of moderately calcified, non-tortuous lesion in superficial femoral artery (sfa) through pedal access of the posterior tibial artery (pt) with 6f sheath.During oad removal resistance was felt and perforation was observed.A foam sealant agent was used to control the bleeding and the patient was transferred to acute care for surgical intervention.Surgical repair was completed without complication.As of (b)(6) 2025 the patient remained in inpatient status, in stable condition.In the physician's opinion, the sheath was the cause of the event.
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 2.0 solid stealth 360 peripheral orbital atherectomy device (oad) was successfully used for treatment of moderately calcified, non-tortuous lesion in superficial femoral artery (sfa) through pedal access of the posterior tibial artery (pt) with 6f sheath.During oad removal resistance was felt and perforation was observed.A foam sealant agent was used to control the bleeding and the patient was transferred to acute care for surgical intervention.Surgical repair was completed without complication.As of (b)(6) 2025 the patient remained in inpatient status, in stable condition.In the physician's opinion, the sheath was the cause of the event.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis, and detailed analysis were performed on the returned device.The reported difficulty removing the oad from the introducer sheath, and perforated vessel could not be confirmed through analysis due to the operational context of the reported issues.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 difficulty removing the oad from the introducer sheath, and perforated vessel appear to be related to circumstances of the procedure.There was no damage or abnormalities identified with the driveshaft or handle assembly that would have contributed to the reported complaint.However, detailed analysis showed that the oad had experienced stall events near the end of the procedure.It is unknown if the stall events are related to the reported compliant.A conclusive cause for the reported perforation of vessels, and the relationship to the product, if any, cannot be determined.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: d9, g3, g6, h2, h3, h6.H6: codes 4755, 4118, 3233, 11 no longer apply.

• 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: 22621527
• Report Number: 3004742232-2025-00211
• Device Sequence Number: 10078943
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)270131(10)562620-1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/02/2025

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 Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 562620-1
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/26/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown