MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED THE CARDIOVASCULAR SYSTEMS, INC. (CSI) DIAMONDBACK 360 CORONARY ORBITAL ATHERECT; CATHETER, CORONARY, ATHERECTOMY

Patient Problems Exsanguination (1841); Cardiac Perforation (2513)

Event Date 01/15/2024

Event Type  Death  

Event Description

(csi) cardiovascular systems inc.Atherectomy device causing perforation of the coronary artery and subsequently death the cardiovascular systems, inc.(csi) diamondback 360 coronary orbital atherectomy system (oas).I have been the cath lab director at (b)(6) hospital in (b)(6) twice.I am a busy interventional cardiologist.I have been board-certified in cardiology for 20 years.This case i am reporting happened with my partner where the csi atherectomy catheter was used appropriately by my partner with the support of the company representative.The device created a massive perforation of the right coronary artery that was unsalvagable resulting in patient death.Over the last 2 years, i have seen in several hospitals i go to, 3 deaths related to the same device by 3 other operators.The standard of care has been rotational atherectomy for decades which is safer than this pretty aggressive device.Every conference i go to and every interventionalist i have met over the years in major academic hospitals show or mention a case of massive perforation.Even in the board exam, it was hinted at that.I believe this is a potentially dangerous device despite the company trying to talk down the serious orbital damage to the blood vessel.There are safer options nowadays with shockwave lithotripsy or even rotational atherectomy.If there is no way to withdraw this device from being used in the coronary arteries in the market - i suggest making it very difficult to use it except in operators who do 20 or more rotational atherectomies a year yes, the 3-4 operators who had some deaths with this device use it only very few times a year and the industry company representatives tend to push more doctors to do it and claim it to be a safer device.

• Brand Name: THE CARDIOVASCULAR SYSTEMS, INC. (CSI) DIAMONDBACK 360 CORONARY ORBITAL ATHERECT
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 18757858
• MDR Text Key: 335996782
• Report Number: MW5151792
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White