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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The diamondback 360® peripheral orbital atherectomy system instructions for use manual states that thrombus is a potential adverse event that can occur with use of the system.Additional input was requested from the physician regarding whether csi caused or contributed to the reported observation of thrombus, but no reply was received.Therefore, the event is being reported.Device analysis conclusion: the oad and guide wire were received at csi for analysis.The wire was engaged in the oad, but the exposed section of wire did not appear damaged.Presence of biological material was noted on the oad crown and between the crown and driveshaft tip bushing.Examination of the areas of adhered material did not reveal any damage that would have contributed to the material accumulation.The morphology and exact root cause of the accumulation is unknown.There were no observations of damage or abnormalities that would have contributed to the reported complaint of thrombus.The oad was tested and functioned as intended.At the conclusion of the device analysis investigation, the report that the oad became stuck on the wire was confirmed.The reported observation of thrombus during the procedure could not be confirmed through analysis.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.Csi id: (b)(4).
Event or Problem Description
Thrombus was observed in the tibioperoneal trunk following use of a stealth orbital atherectomy device.The patient was treated overnight with tissue plasminogen activator.The thrombus was then extracted successfully with an additional non-csi device.The oad reportedly also became stuck on the viperwire, though that event is not considered a reportable malfunction.

• Brand Name: STEALTH PLUTO PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11197366
• Report Number: 3004742232-2021-00012
• Device Sequence Number: 642809
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)220831(10)339461
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/19/2021

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: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 339461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/19/2021
• 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