MAUDE Adverse Event Report: CSI / CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360; CATHETER, CORONARY ATHERECTOMY

Catalog Number DBEC-13

Device Problem Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802)

Event Date 10/17/2019

Event Type  Death  

Event Description

Pt had coronary atherectomy done using csi device.Device jumped forward and lodged in the artery and then the tip of the viperwire broke off in coronary artery.Fda safety report id# (b)(4).

• Brand Name: DIAMONDBACK 360
• Type of Device: CATHETER, CORONARY ATHERECTOMY
• Manufacturer (Section D): CSI / CARDIOVASCULAR SYSTEMS, INC.
• MDR Report Key: 9244270
• MDR Text Key: 164086255
• Report Number: MW5090658
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: DBEC-13
• Device Lot Number: 281133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Death