MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

Model Number PRD-SC30-MICRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The diamondback360® peripheral orbital atherectomy system instructions for use manual states that distal embolization is an adverse event that can occur during use of the device. The device history record for the reported oad was unable to be reviewed, as the lot number was not provided. (b)(4).

Event Description

The stealth peripheral orbital atherectomy device (oad) was operated on low, medium and high speeds for one treatment pass each, in a calcified tibioperoneal trunk artery. It is believed that damage to the intima occurred, as intima debris was noted to travel distally to the foot. Balloon angioplasty was performed to push the debris into a nearby collateral vessel. The area of the vessel wall where suspected intima damage occurred did not require additional intervention. Upon removal, tissue was observed on the crown of the oad. The patient was in stable condition.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, mn ; 2591600
• MDR Report Key: 9749610
• MDR Text Key: 180725900
• Report Number: 3004742232-2020-00054
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/25/2020 Patient Sequence Number: 1