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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Entrapment of Device (1212); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Vascular System (Circulation), Impaired (2572); No Code Available (3191)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis.An examination of the handle assembly and brake guide wire hypotube found an area of surface wear and galling along the hypotube.Although the root cause of this is unknown, it is possible that the surface wear and galling may have contributed to the device not spinning properly, however this could not be confirmed.When tested, the oad functioned as intended with no anomalies noted.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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
During treatment of a 80% stenosed lesion in the anterior tibial artery with a diamondback peripheral orbital atherectomy device (oad), one pass was performed on low speed and two on medium speed.When high speed was selected, the oad lost speed when engaging the distal lesions, but was able to pass through.When the oad was moved proximal, the device shut down and became stuck on the guide wire due to possible vessel spasm.The crown was able to be removed from the guide wire and navigated to the superficial femoral artery, however it would not spin.The system was restarted, however this did not resolve the issue.Following removal of the oad, no flow was present in the vessel.Nitroglycerin was administered and balloon angioplasty was performed, following which the vessel was open and patent.Following balloon angioplasty, a type b dissection was noted which was related to multiple balloon inflations.The dissection was resolved by inflating another balloon at the site for two minutes.The patient was in stable condition following the procedure.

• 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; st. paul MN 55112
• MDR Report Key: 8741271
• Report Number: 3004742232-2019-00168
• Device Sequence Number: 2534745
• Product Code: MCX
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210228(10)259590
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 259590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention