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

Model Number	DBP-CART-125MIC145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolus (1830); Vascular System (Circulation), Impaired (2572)
Date of Event	10/10/2019
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.(b)(4).
Event or Problem Description
A severely calcified, 90% stenosed lesion in the posterior tibial artery (pt) was treated with a 1.25mm diamondback exchangeable peripheral orbital atherectomy device (oad) followed by balloon angioplasty.The peroneal was then noted to have sluggish flow, and a guide wire was placed and balloon angioplasty was performed.An embolic filter was placed proximal to the anterior tibial artery (at) and a 2.0mm diamondback exchangeable cartridge was used to treat the 80% stenosed popliteal and superficial femoral arteries (sfa) on low, medium and high speeds.The popliteal and sfa were then treated with balloon angioplasty.The patient was noted to have pulses via ultrasound, but the foot appeared red and mottled.The leg of the patient from foot to mid-thigh turned red and blue, and the physician diagnosed the patient with livedo reticularis post cardiac catheterization and cholesterol crystal embolisation.The patient was placed on a heparin drip and treated with an integrin bolus.The leg was kept warm and monitored overnight.The following morning, the condition had mostly resolved and the physician expectation was a full recovery.

• Brand Name: DIAMONDBACK 360 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: 9283984
• Report Number: 3004742232-2019-00289
• Device Sequence Number: 10794951
• Product Code: MCW
• UDI-Device Identifier: 10852528005923
• UDI-Public: (01)10852528005923(17)210228(10)260025
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 02/28/2021
• Device Model Number: DBP-CART-125MIC145
• Device Catalogue Number: 7-10031-01
• Device Lot Number: 260025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/06/2019
• 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
• Patient Age: 65 YR