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

Model Number	RAD-SC30-150
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
A stealth peripheral orbital atherectomy device (oad) was used via left radial access to successfully treat lesions in the superficial femoral, popliteal, and tibioperoneal trunk arteries.The oad was advanced to the anterior tibial artery and treatment was started.The oad stopped spinning and was removed, and the procedure was completed with balloon angioplasty.During recovery, the patient complained of foot pain upon waking up from sedation.Ultrasound was performed and flow was confirmed to be present.It was determined that extravasation had occurred and the patient was transferred to a hospital where a fasciotomy was performed.The patient was in stable condition following this procedure.

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 11979025
• Report Number: 3004742232-2021-00214
• Device Sequence Number: 4015250
• Product Code: MCW
• UDI-Device Identifier: 10850000491318
• UDI-Public: (01)10850000491318(17)221031(10)348283
• 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): 06/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: RAD-SC30-150
• Device Catalogue Number: 7-10059-06
• Device Lot Number: 348283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/10/2021
• 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: Hospitalization; Required Intervention