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

Model Number	DBEC-125
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not yet returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.If the device is received, an analysis will be performed and a supplemental report will be submitted.(b)(4).
Event or Problem Description
During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), the crown became detached in the patient.The target lesion was 95% stenosed and located in a tortuous region of the circumflex.The region was unable to be stented.During treatment with the oad, the crown was observed to be detached.The crown was retrieved.There were no patient complications associated with the event.Additional information was requested for this event, however it was reported to csi that no additional information was available.
Additional Manufacturer Narrative
The reported oad was received for analysis.The device was observed to have a driveshaft fracture on the distal side of the crown weld.The crown was intact.Scanning electron microscopy was performed and identified evidence of fatigue striations on the fractured driveshaft filars.At the conclusion of the device analysis investigation, the report of a device fracture was confirmed.However, the root cause of the fracture could not be conclusively confirmed.The device history record for this oad lot number has been reviewed.One device from this lot number was scrapped during review due to a crown weld issue.This was not found to be present during analysis of the reported device.(b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7918559
• Report Number: 3004742232-2018-00295
• Device Sequence Number: 11099409
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)191130(10)208776
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 11/02/2018

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: 11/30/2019
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 208776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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