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

Model Number	DBEC-125M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No code available - slow flow.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
During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), a slow flow event occurred.The target lesion was 90% stenosed and located in the proximal left anterior descending artery (lad).The oad approached the lesion using five passes on low speed, however the device was unable to cross the lesion.Transient slow flow was noted and was treated using a vasodilator.When the oad was removed it became stuck in the lesion, and was able to be removed with no patient consequences noted.The procedure was completed with stent placement and the patient was stable.

• 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: 7334980
• Report Number: 3004742232-2018-00055
• Device Sequence Number: 16156495
• Product Code: MCX
• UDI-Device Identifier: 10852528005336
• UDI-Public: (01)10852528005336(17)191031(10)205967
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: DBEC-125M
• Device Catalogue Number: 7-10000-01
• Device Lot Number: 205967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/13/2018
• 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: 66 YR