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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/04/2021

Event Type  Death  

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 the reported oad could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.The instructions for use for the coronary oas warn: "for every 30 seconds of treatment, a rest period of equal time is recommended with a maximum treatment time of 5 minutes per oad." the patient had severe aortic stenosis, and the opinion of the physician was that the patient's preexisting medical state contributed to the desaturation experienced during the procedure.A request was made as to the physician's opinion on the cause of the patient's death, but the physician was not able to provide one.(b)(4).

Event Description

A patient had been turned down for surgical intervention.A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a long, severely atherosclerotic lesion in the mid left anterior descending coronary artery.Multiple treatments were performed for 45-60 second each.The physician was aware treatments should be performed for 30 seconds followed by 30 seconds of rest.The patient desaturated and experienced slow flow.A ventricular support device was inserted, the patient was intubated, and adenosine and cardene were administered.The patient was revived.The oad was removed, and stent placement was performed.The patient remained intubated with the ventricular support device and was transferred to the intensive care unit.The patient expired on (b)(6) 2021.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 11378763
• MDR Text Key: 233500208
• Report Number: 3004742232-2021-00064
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

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
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR