MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED 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 Atrial Fibrillation (1729); Death (1802)

Event Date 06/27/2016

Event Type  Death  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The lot number was not recorded and could not be obtained.(b)(4).Discarded by facility.

Event Description

It was reported that after a coronary orbital atherectomy procedure, the patient went into atrial fibrillation and eventually expired.The target lesion was located in the left anterior descending (lad) artery.The physician advanced a csi viperwire guide wire across the lesion and loaded a csi orbital atherectomy device (oad) onto it.The physician performed four runs at low speed using the oad and followed-up atherectomy by deploying a stent in the lad.While in holding, the patient went into atrial fibrillation.Emergency measures were taken, but the patient was unable to recover and expired.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5822651
• MDR Text Key: 50450126
• Report Number: 3004742232-2016-00080
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2016

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: Physician
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/26/2016
• 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): Death