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	Thrombus (2101); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
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
It was identified that during a coronary atherectomy procedure using a csi orbital atherectomy device (oad), a thrombus occurred.This was identified during an optical coherence tomography (oct) image review following the procedure.The procedure was completed with no adverse events reported.
Event or Problem Description
The observed thrombus was located at proximal reference vessel and at stent.No thrombus was observed on angiography.
Additional Manufacturer Narrative
Per physician review, this observation of thrombus was not associated with any adverse event to the patient and was a subclinical finding associated with the intravascular imaging core lab analysis required as part of a clinical trial.Based on this review, this event no longer meets the definition of a reportable serious injury.Csi id (b)(4).

• 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: 7768763
• Report Number: 3004742232-2018-00244
• Device Sequence Number: 19345433
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)200131(10)214898
• 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: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 01/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 214898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 03/14/2019
• 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: Life Threatening; Other
• Patient Age: 75 YR