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

Model Number	PRD-SC30-125
Medical Device Problem Codes	Melted (1385); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8780979
• Report Number: 3004742232-2019-00174
• Device Sequence Number: 16803936
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)220228(10)261198
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR