MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEIVCE

Model Number	PRD-SC30-MICRO
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned to csi.Analysis revealed adhered biological material on the driveshaft proximal to the crown section.The material did not cause any resistance when passing a wire through.The biological material accumulation may be related to the reported complaint, however, cannot be confirmed.No damage or abnormalities were observed with the driveshaft or crown that could have contributed to the perforation or accumulating material.Diagnostic analysis revealed two low speed treatments that ended in a stall event.The root cause of the reported event was unable to be 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.Investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).
Event or Problem Description
During treatment in the distal anterior tibial artery (at) and dorsalis pedis artery (dp), the stealth 360 orbital atherectomy device (oad) made a slipping noise.The oad was in the subintimal space.The oad was removed and tissue was observed on the sheath.Angiographic imaging revealed a perforation of the dp.Balloon tamponade was performed to resolve the perforation.Balloon angioplasty was performed to complete the procedure.The patient was stable.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEIVCE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16702076
• Report Number: 3004742232-2023-00095
• Device Sequence Number: 19752194
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)250131(10)471289-1
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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: 01/31/2025
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 471289-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White