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

Model Number GWC-12325LG-FLP

Device Problem Positioning Failure (1158)

Patient Problem Cardiac Arrest (1762)

Event Date 04/17/2018

Event Type  Death  

Event Description

On (b)(6) 2018, pt underwent a left heart catheterization, selective coronary angiography, vein graft angiography, aortic root angiography and orbital atherectomy.During the orbital atherectomy, 1.25mm coronary csi device was used but stalled twice.The coronary csi device was withdrawn and it was noted that the guidewire was fractured and a portion of the guidewire was retained in the coronary artery.During the angiography, a coronary perforation discovered and the appropriate steps were taken to manage the pt's critical condition and the coronary perforation during the procedure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC. ; 1225 old hwy 8nw ; st. paul MN 55122
• MDR Report Key: 7495667
• MDR Text Key: 107708685
• Report Number: 7495667
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 10855680
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2018
• Distributor Facility Aware Date: 04/17/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Weight: 62