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

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Perforation of Vessels (2135)
Date of Event	08/13/2021
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.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 coronary orbital atherectomy device instructions for use states that perforation is a possible adverse event which can occur with use of the diamondback coronary orbital atherectomy device.Csi id# (b)(4).
Event or Problem Description
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a heavily calcified, 90-95% stenosed lesion in the proximal and mid circumflex artery.The vessel was tortuous and 2.5-3.0mm in diameter.Four treatments were performed with the oad followed by balloon angioplasty.Imaging following balloon angioplasty did not reveal any issue in the vessel.A stent was inserted and the guideliner was advance for additional support.The patient experienced chest pain, and a small perforation was observed in the proximal vessel.A covered stent was placed to resolve the perforation.The patient was stable following the procedure.The physician was unable to determine if the oad caused or contributed to the perforation.

• 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: 12365219
• Report Number: 3004742232-2021-00296
• Device Sequence Number: 14481987
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230228(10)369618-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 08/25/2021

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: 02/28/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 369618-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/25/2021
• 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 Age: 77 YR
• Patient Weight: 95