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

Model Number	PRD-SC30-MICRO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that during treatment of lesion in the tibial artery using the stealth 360 peripheral orbital atherectomy device (oad) the vessel became occluded.An unspecified balloon was used in the posterior tibial artery (pt) to complete the procedure.Nitroglycerin was administered.The patient was in stable condition.No further information was provided.
Event or Problem Description
It was reported that during treatment of moderately calcified, non-tortuous, 70% stenosed lesion in posterior tibial artery (pt) using a stealth 360 peripheral orbital atherectomy device (oad) the vessel became occluded distal to treatment area.A 6fr slender sheath was used over the wire and viperslide lubricant.An unspecified balloon was used in the (pt) to reopen the artery and complete the procedure.Nitroglycerin was administered.The patient was in stable condition.In the opinion of the physician, vessel occlusion was caused by calcium shedding and occurred only because the oad was being used in the vessel.Additional information was received from abbott senior account manager on (b)(6) 2025.The date of event will be estimated as (b)(6) 2025.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported obstruction and related medical intervention appear to be related to operational context.In this case, it is likely that the obstruction is due to the patient¿s disease state and/or use techniques employed; however, since the device was not returned this could not be 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.B3: date of event will be estimated as 02/03/2025.H6: codes 4118, 3233, and 11 no longer apply.H6 investigation conclusion code 22: the stealth 360® peripheral orbital atherectomy system instructions for use manual states that occlusion of vessels is a potential adverse event that may occur and/or require intervention with use of the system.

• 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: 21577030
• Report Number: 3004742232-2025-00049
• Device Sequence Number: 8431332
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)260331(10)529962-1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/06/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: PRD-SC30-MICRO
• Device Lot Number: 529962-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White