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

Model Number PRD-SC30-MICRO

Device Problems Contamination (1120); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

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

A coronary stealth orbital atherectomy device (oad) was used to successfully treat a lesion in the posterior tibial artery. A second, severely calcified lesion in the anterior tibial artery was then going to be treated with the oad via an antegrade approach. However, when attempting to pass the guide wire through the oad, the guide wire would not pass the crown of the driveshaft. It appeared there was something obstructing the distal opening of the driveshaft. The wire was unable to pass through the oad and treatment of the anterior tibial artery was aborted. It was noted that the control knob of the oad was in the correct placement for wire pass through. It was planned to bring the patient back at a later date to treat the anterior tibial artery lesion. It was noted there was no patient complications during the procedure.

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE,
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 9232968
• MDR Text Key: 201687579
• Report Number: 3004742232-2019-00274
• 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: 11/06/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2021
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 286393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial