MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	PRD-SC30-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was receive at csi for analysis.A visual examination revealed adhered biological material on the driveshaft crown.The fluid flow rate of the oad was tested and found to have met device specification.When tested, the oad functioned as intended.At the conclusion of the device analysis investigation, the report that an occlusion occurred, could not be confirmed through analysis.The accumulation of the adhered biological material observed on the driveshaft crown may have contributed to the reported occlusion, however this could not be confirmed through analysis, and the morphology and exact root cause of the accumulation was unknown.The physician did not speculate as to what may have caused the possible occlusion.The stealth gen2 peripheral orbital atherectomy system instructions for use states that a vessel occlusion is an adverse event that may occur and/or require intervention as a result of the use of this device.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4) suggested code is slow/no flow.Results code: (b)(4) -suggested code is biological material present on device.Csi id: (b)(4).
Event or Problem Description
The stealth peripheral orbital atherectomy device (oad) was selected for treatment of the popliteal artery, which was calcified.The oad was operated on low speed for three treatment passes, with breaks between each pass.Imaging was performed and revealed what may have been an occlusion, as the posterior tibial and anterior tibial arteries were not visible on the angiography.Balloon angioplasty was performed to restore flow.A closure device was used to obtain hemostasis in the groin access site.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 12085739
• Report Number: 3004742232-2021-00241
• Device Sequence Number: 3464941
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)220831(10)341023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 08/31/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 341023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 113