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

Model Number 3070

Device Problems Break (1069); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem Perforation (2001)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

During the coronary angio, the csi orbital atherectomy catheter became stuck in the lcx (left circumflex artery), causing a perforation of the lcx.The md was able to pull the device back successfully and place a covered stent across the perforation.While attempting to place a covered stent across a perforation in the lcx, the stent would not advance.When the md attempted to remove the stent, the stent was stripped off the balloon.The md was successfully able to remove both the stent and balloon catheter with no harm to the patient.The md was able to cover the perforation with 2 biotronik pk papyrus-covered stents.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 12922986
• MDR Text Key: 281660501
• Report Number: 12922986
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/16/2021

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 Operator: Health Professional
• Device Model Number: 3070
• Device Catalogue Number: 3070
• Device Lot Number: 374109-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other