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

Model Number PRD-SC30-125

Device Problems Melted (1385); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2019

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

During a procedure, a mild to moderately calcified target lesion in the superficial femoral artery was treated with a stealth peripheral orbital atherectomy device (oad) via a femoral approach.When the oad was treating the lesion, fluid was noted to be spraying out of a hole in approximately the mid-point of the driveshaft.The section of the driveshaft spraying liquid was still located outside of the body.A second oad was used to complete the procedure along with balloon angioplasty, and there were no patient complications.

Manufacturer Narrative

The reported device was received for analysis.Visual observation identified a hole that had been melted in the driveshaft sheath.There was evidence of compression damage to the sheath that indicates the sheath may have been compressed enough to interact with the spinning driveshaft.This compression could melt a hole in the sheath material due to friction-induced heat, however, the exact root cause of the melted, deformed sheath material is unknown.During testing, fluid was injected through the handle assembly and was observed to flow through the entire device, exiting at the crown, but also leaked at the area of the melted hole.The oad function was tested, and the oad spun at all speeds and functioned as intended.At the conclusion of device analysis, the reported event of saline leaking from a hole in the driveshaft was confirmed.The device history record for this oad 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: 8780979
• MDR Text Key: 150716844
• Report Number: 3004742232-2019-00174
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)220228(10)261198
• Combination Product (y/n): N
• PMA/PMN Number: K110389
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 70056-03
• Device Lot Number: 261198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR