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

Model Number	DBEC-125
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Chest Pain (1776); Death (1802); Perforation of Vessels (2135)
Date of Event	07/29/2020
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
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a lesion in the proximal right coronary artery.Several treatments were administered without issue.Throughout the procedure the patient experienced nausea and vomiting.Glideassist mode was used to successfully advance the oad to mid lesion, and several treatment passes were administered on low speed.Per the physician, it felt like the device had jumped, however this was not visibly seen on the angiogram.Imaging was performed, and no issues were noted.One more treatment pass was performed, and the oad stalled.The physician was advised to stop treatment and remove the device.Imaging revealed a vessel perforation, and the patient complained of chest pain.A balloon was inserted to tamponade the vessel, and a right ventricle infarction occurred as a result.The patient went into pulseless electrical arrest and coded.Advanced life support was administered for 40 (forty) minutes.A pericardial tap was performed, and a balloon pump was inserted.The patient was intubated.When the patient was stable, the perforation was re-assessed and confirmed to be sealed.The patient expired two (2) days later, due to the right ventricular infarction.In the opinion of the physician, the perforation was an outcome that they were prepared for, due to the tortuosity and severe calcium present in the vessel.In the opinion of the physician, the perforation was not related to the patient's death.The right ventricular infarction was caused by balloon expansion that was performed to tamponade the vessel.

• 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: 10464672
• Report Number: 3004742232-2020-00257
• Device Sequence Number: 3120109
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211130(10)297025
• 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): 08/28/2020

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: 11/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 297025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR