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	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
The diamondback coronary orbital atherectomy device (oad) could not be advanced through a narrow lesion in the right coronary artery (rca) via femoral approach despite use of the viperwire to help direct and despite the use of a threader catheter.The device was turned on in order to treat the proximal part of the lesion so that the device could advance farther.After two treatments a flow-limiting dissection was identified in the rca.Orbital atherectomy was discontinued at that time.Resistance was encountered when the oad was removed.At that time, the dissection was noted to be flow-limiting.A guide wire would not cross the dissection, and a balloon was used to treat the dissection, but the artery did not open.The patient then complained of chest pain.Pericardial effusion was ruled out, and attempts to cross the dissection with a guide wire were continued.A balloon pump was placed and the patient no longer had chest pain and the pt segments became normal.The patient was discharged (b)(6) 2018.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 7885493
• Report Number: 3004742232-2018-00282
• Device Sequence Number: 16200330
• Product Code: MCW
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)180930(10)170461
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/18/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 170461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 75