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	Death (1802); ST Segment Elevation (2059); No Code Available (3191)
Date of Event	11/14/2018
Type of Reportable Event	Death
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.(b)(4).
Event or Problem Description
Following a coronary atherectomy procedure using a csi orbital atherectomy device (oad), no reflow occurred and the patient expired.The target lesion was 90% stenosed and located in the mid right coronary artery (rca).The lesion was treated with multiple passes of the oad followed by balloon angioplasty, and this sequence was repeated three times.Following the third balloon inflation, st elevations were noted and the patient became unresponsive and no flow was noted.Insertion of a ventricular assist device was attempted however it was unable to be used as the valve was too narrow.Chest compressions were performed and the patient appeared to stabilize momentarily, however it was reported that the patient then expired.

• 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: 8121611
• Report Number: 3004742232-2018-00358
• Device Sequence Number: 1657001
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)190731(10)196786
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/30/2018

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: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 196768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/30/2018
• 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: Death
• Patient Age: 82 YR