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

Model Number PRD-SC30-MICRO

Device Problems Entrapment of Device (1212); Unintended System Motion (1430)

Patient Problem Perforation of Vessels (2135)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(4).

Event Description

The stealth peripheral orbital atherectomy device was selected for treatment of a proximal lesion located in the anterior tibial artery. The vessel was 70% stenosed, and 3mm in diameter. The oad was operated on low speed and jumped forward on the first treatment pass. On the third treatment pass the oad stopped spinning. All expected leds were visibly lit at this time. Repositioning of the oad was attempted, however it was stuck on the guide wire. Glideassist mode was used to remove the oad from the patient's body and the guide wire remained in place. A vessel perforation was observed after the oad was removed. Balloon angioplasty was performed at 8 atmospheres for one minute. Imaging still showed extravasation and a blood pressure cuff was placed below the knee and inflated for one hour. After several hours of monitoring the patient, imaging showed no signs of a perforation and the patient was discharged home.

• 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: 10139376
• MDR Text Key: 194679591
• Report Number: 3004742232-2020-00154
• 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,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 314836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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: 06/10/2020 Patient Sequence Number: 1