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

Model Number	VPR-GW-17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive sincethe reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The material inspection report for this guide wire 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.(b)(4).
Event or Problem Description
A peripheral orbital atherectomy procedure was planned.The target lesion was an 85% stenosed, moderately to severely calcified lesion that was located in the tibioperoneal trunk.The lesion was 100mm in length and located in a 4mm diameter section of the artery.The lesion was wired with a non-csi guide wire, but access was lost.After rewiring the lesion with a viperwire guide wire, a type c dissection was noted.A decision was made to not continue with orbital atherectomy, and percutaneous transluminal angioplasty (pta) was performed to resolve the dissection.The procedure was completed with pta and a stent.The patient's status was good following the procedure.

• Brand Name: DIAMONDBACK 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: 8557754
• Report Number: 3004742232-2019-00111
• Device Sequence Number: 13917685
• Product Code: MCW
• UDI-Device Identifier: 10852528005084
• UDI-Public: (01)10852528005084(17)200831(10)241348
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151260
• 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): 04/26/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: VPR-GW-17
• Device Catalogue Number: 72023-02
• Device Lot Number: 241348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/26/2019
• 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