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

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/05/2019
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.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.The diamondback 360 coronary orbital atherectomy system instructions for use states that dissection is a possible adverse event which may occur with use of the system.Csi id# (b)(4).
Event or Problem Description
During treatment with a viperwire and coronary diamondback orbital atherectomy device (oad) a flow-limiting dissection occurred.The target lesion was located in a diffusely diseased section of the left anterior descending artery (lad).The lesion was stenosed at 70% and was approximately 3.00 mm in diameter, with minimal tortuosity in the treatment area, and higher tortuosity in the distal lad.The lesion was wired via the radial approach, and the oad was operated for one treatment in the mid-lad, when a flow-limiting dissection was noted in the distal portion of the lad, near the viperwire.A stent was placed to resolve the dissection, and flow was restored.The patient was discharged to the progressive care unit (pcu) and stayed overnight.There were no other patient complications reported.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8739815
• Report Number: 3004742232-2019-00165
• Device Sequence Number: 11404494
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)201031(10)11042801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 06/27/2019

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: 10/31/2020
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/27/2019
• 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: Required Intervention