MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-125MICRO145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis the device was not returned for analysis; therefore, an analysis of the actual complaint device is not possible.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.(b)(4) discarded by facility.
Event or Problem Description
It was identified that during a peripheral orbital atherectomy procedure, a type c dissection occurred.The event was identified by a third party vendor, core lab.Core lab reviewed all procedural angiograms as part of a csi clinical trial.The target lesion originated in the distal popliteal artery and extended into the peroneal artery.The physician used multiple guide wires and guide catheters, as well as multiple balloon inflations to access and cross the lesion.A csi viperwire guide wire was advanced across the lesion and a csi orbital atherectomy device (oad) was loaded onto it.The physician performed multiple runs at low, medium and at high speed.Post-atherectomy angiography did not reveal any complications.The physician removed the csi oad and guide wire and re-wired the lesion with a mailman guide wire.Atherectomy was followed-up with balloon angioplasty and stent deployment.Post-procedure angiography did not reveal any complications and the patient status remained stable throughout the procedure.Follow-up review by core lab identified a type d dissection; however, no complications were noted by the treating physician during the procedure.The core lab angiogram evaluation was reviewed by csi for potential adverse events on 29 april 2016.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 5684773
• Report Number: 3004742232-2016-00057
• Device Sequence Number: 13495672
• Product Code: MCW
• UDI-Device Identifier: 10852528005190
• UDI-Public: (01)10852528005190(17)160831(10)109049
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

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: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 109049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2016
• Initial Report FDA Received Date: 05/27/2016
• 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: Other