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

Model Number DBEC-125M

Device Problems Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Great Vessel Perforation (2152)

Event Date 01/11/2023

Event Type  Injury  

Event Description

The diamondback 360 coronary orbital atherectomy system was inside the patient and froze on the wire while in procedure.Md was unable to get the device to start again.Device was removed from body as a whole which shut down the lad vessel in the heart.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 16245671
• MDR Text Key: 308158353
• Report Number: 16245671
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/12/2023

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
• Device Model Number: DBEC-125M
• Device Catalogue Number: 7-10000-01
• Device Lot Number: 442461-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization