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

Model Number SIP-3000

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2019

Event Type  malfunction  

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.Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

During a peripheral procedure to treat a target lesion in the popliteal artery, the stealth saline infusion pump repeatedly went into standby mode.Troubleshooting was performed, including setting up a second orbital atherectomy device, however, the issue was not resolved.The procedure was completed with a scoring balloon.It was noted that the procedure was delayed greater than thirty (30) minutes due to the issue.

Manufacturer Narrative

The reported oas pump was returned for analysis.Visual examination revealed a fracture in the saline pump head door.Power to the pump was applied, and the pump would default to standby mode after approximately one second.The pump motor was examined, and a broken magnetic tach wheel was identified.This damage is consistent with the pump being dropped, however, the exact cause of the fracture was unable to be determined.Functional testing of the pump was unable to be continued as the tach wheel was unable to be replaced.At the conclusion of device analysis, the reported event of the pump not powering the oad was confirmed.The instructions for use states to not use an oad or oas pump if it was dropped onto a hard surface from a height of 12 inches (30cm), because the device may be damaged and fail to operate properly.The device history record for this oas pump lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id# (b)(4).

• Brand Name: STEALTH 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 55112
• MDR Report Key: 9632252
• MDR Text Key: 186729092
• Report Number: 3004742232-2020-00021
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIP-3000
• Device Catalogue Number: 70058-13
• Device Lot Number: 56809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1