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	08/20/2020
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 device instructions for use states that perforation is a possible adverse event which can occur with use of the diamondback 360 coronary orbital atherectomy device.(b)(4).
Event or Problem Description
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a lesion in the left circumflex coronary artery (lcx).The vessel was occluded with grafts, and there was no flow initially through the vessel.Wiring of the vessel was challenging and done with two non-csi guide wires.A wire exchange was performed, and the oad was placed at the lesion.On the first treatment, the oad made a stalling noise, but did not stop spinning.During the second oad treatment, the patient presented with chest pain.Imaging revealed that flow had not improved.The oad was removed, and imaging then showed a perforation in the proximal lcx.Balloon angioplasty and stenting was performed.In the opinion of the physician, the initial non-csi guide wires created or lifted a dissection flap, and the oad exacerbated the dissection into a perforation.Following the procedure, the patient was stable and the vessel exhibited adequate flow.

• 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
• MDR Report Key: 10455424
• Report Number: 3004742232-2020-00260
• Device Sequence Number: 3960615
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220228(10)313840
• Combination Product (Y/N): N
• 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): 08/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 313840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/26/2020
• 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: 82 YR
• Patient Weight: 77