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

Model Number DBEC-125M

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2023

Event Type  Injury  

Event Description

Diamondback 360 1.25mm 145cm coronary orbital atherectomy, lot# 462554-1, exp date [redacted date].Five passes of the diamondback 1.25 orbital atherectomy device performed in the rca (right coronary artery).Crown of diamondback catheter broke off in rca.Team retrieved crown from distal rca at 17:01.The crown separated from the shaft of the catheter.Team was unable to complete the pci and patient left cath lab with some asymptomatic ste (st segment elevation) which was resolving.Md suspected arterial dissection and did not want to inject contrast which may further the dissection.Equipment was pulled out from the patient and procedure stopped.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 16263379
• MDR Text Key: 308359205
• Report Number: 16263379
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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: 462554-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32485 DA
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White