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

Model Number DBEC-125

Patient Problem Insufficient Information (4580)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Csi wire sheared off during procedure.Product removed from the body.

• 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: 17479305
• MDR Text Key: 320589040
• Report Number: 17479305
• 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: 07/27/2023,07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 7-10060-09
• 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: 07/27/2023
• Date Report to Manufacturer: 08/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA