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

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In good faith, please note that due to a vendor system batch processing error, the individuals responsible for regulatory reporting at csi were not notified of this event, resulting in submission of this report outside of the 30 day due date.The vendor has identified the root cause of this error and corrective actions are being implemented.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The reported device was not returned as there was no adverse event identified by the treating physician and the device was discarded per the hospital's procedures.  while inconclusive, there was no evidence that the visual observation of dissection was the result of the use of the orbital atherectomy device or that it caused or contributed to an adverse event for this patient.(b)(4).
Event or Problem Description
Csi was notified that a study core lab reported a visual observation of a dissection type c after use of the orbital atherectomy device during an angiographic image review following the procedure.The final angiographic morphology had no observation of dissection with a timi flow of 3.No adverse events or angiographic complications relating to dissection were reported by the treating physician.

• 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: 8241392
• Report Number: 3004742232-2019-00022
• Device Sequence Number: 1594098
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)190930(10)201984
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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: 09/30/2019
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 201984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 01/11/2019
• 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: Other
• Patient Age: 52 YR
• Patient Weight: 165