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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ventricular Fibrillation (2130); Patient Problem/Medical Problem (2688)

Event Date 11/29/2018

Event Type  Injury  

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.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

The patient experienced ventricular fibrillation following three treatments at low speed with a diamondback coronary orbital atherectomy device.The patient had presented to the clinic a week prior to the reported event for a catheterization due to st-elevation myocardial infarction.At that time, the physician was able to work on the left artery but the right was occluded, and the right coronary artery did not respond to angioplasty.The patient was brought back in on the date of the event for atherectomy in the rca.The lesion was about 50% calcified and quite stenotic.Following three treatments with the oad, the physician did not feel adequate progress was being made, so he removed the oad.There was no reported issue with the device.Upon removal of the oad the patient coded.Cardiopulmonary resuscitation was started and the patient was sent to surgery.A coronary artery bypass was performed and the patient recovered and was doing well as of (b)(6) 2018.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 8166488
• MDR Text Key: 130465110
• Report Number: 3004742232-2018-00371
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2018

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
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention