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

Catalog Number DBP-200SOLID145

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 02/28/2018

Event Type  Injury  

Event Description

Patient suffered dissection of right sfa secondary to csi device.While performing an atherectomy, a dissection was noted in the superficial femoral artery, the csi burr device then could not be pulled back and was unable to be removed from pt.Vascular surgeon called and pt transferred to operating room for emergent removal of device in stable condition.

• Brand Name: CSI DIAMONDBACK BURR 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.
• MDR Report Key: 7344735
• MDR Text Key: 102716906
• Report Number: MW5075905
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBP-200SOLID145
• Device Lot Number: 203457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 66