MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 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 Codes	Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2021
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.(b)(4).
Event or Problem Description
A diamondback peripheral exchangeable orbital atherectomy device (oad) was used to treat a chronic total occlusion in the superficial femoral artery.Three treatment passes were performed at low speed and two at high speed.The oad was removed and balloon angioplasty was performed.Angiography was performed of the vessel run off and an embolism was observed in the area of the popliteal artery.A thrombectomy catheter was used and the area improved, however a more distal embolism was observed and flow was lost to the dorsalis pedis.The patient was asymptomatic but was placed on heparin and monitored overnight to address the no flow.As of 15 march, the patient was in stable condition.Per the physician the cause of the embolism was unknown.

• 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: 11575853
• Report Number: 3004742232-2021-00097
• Device Sequence Number: 19732645
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)211130(10)297485
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/26/2021

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: 11/30/2021
• Device Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 297485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/26/2021
• 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
• Patient Weight: 89