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 Cardiopulmonary Arrest (1765); Ventricular Fibrillation (2130)

Event Date 07/02/2019

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.(b)(4).

Event Description

After two treatment passes in the proximal right coronary artery (rca) with the diamondback coronary orbital atherectomy device (oad), the patient fibrillated.The oad was removed from the sheath and defibrillation was performed.Following defibrillation, the patient stopped breathing, cardiopulmonary resuscitation was performed and the patient was intubated.A stent was placed in the proximal rca and post dilated with balloon angioplasty.A guide catheter was advanced to the mid rca and another stent was placed.The patient was transferred to the intensive care unit intubated in stable condition following the procedure.Per the physician, the oad performed as expected and was not the cause of the event.The patient presented with respiratory issues pre-procedure and a low ejection fraction.The patient was not a good candidate for a ventricular assist device due to the state of the iliac vessels.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 8781289
• MDR Text Key: 150724582
• Report Number: 3004742232-2019-00177
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210131(10)255528
• 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: 07/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 255528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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): Hospitalization; Required Intervention