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

Model Number	DBP-EX-200SOL145
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	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The diamondback 360® peripheral orbital atherectomy system exchangeable series instructions for use manual states that slow flow and no reflow phenomenon are potential adverse events that may occur and/or require intervention with use of the system.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.Csi requested the opinion of the physician as to whether oa contributed to the adverse event.However, the physician was unable to form an opinion since imaging was not performed between csi and lithotripsy.Csi id: (b)(4).
Event or Problem Description
The patient's vasculature exhibited two-vessel runoff with the anterior tibial and peroneal arteries open prior to atherectomy with a diamondback exchangeable series orbital atherectomy device (oad).The superficial femoral artery was treated with oa followed by a non-csi device.No flow was then seen on imaging in the peroneal artery.This was resolved with balloon angioplasty, which was applied to the proximal peroneal artery.

• Brand Name: DIAMONDBACK EXCHANGEABLE SERIES 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: 12075432
• Report Number: 3004742232-2021-00237
• Device Sequence Number: 3427783
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)230331(10)373167
• 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): 06/28/2021

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: 03/31/2023
• Device Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 373167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/28/2021
• 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: Other; Required Intervention
• Patient Age: 89 YR