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

Model Number DBEC-125

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

The reported oad was returned for analysis with the non-csi guide catheter and hemostasis valve used during the procedure.A visual examination did not identify any damage to the oad or accessories which would have contributed to the reported event.The oad driveshaft passed through the guide catheter and hemostasis valve with no resistance.The oad was activated with fluid flow through the system and no air bubbles or leaks were observed while the device was operating.The system was then pressurized to identify potential leaks which could have allowed air to ingress into the system.No leaks were observed during this process.During the analysis, an attempt was made to recreate the method utilized during the procedure to aspirate through the saline line injection port.When a vacuum was applied to the saline line injection port, it was confirmed that air was introduced from the handle into the saline line path.Further investigation will be performed in relation to this event.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).

Event Description

During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), an air embolism occurred.The target lesion was located in the left anterior descending artery (lad).Following insertion of the oad prior to atherectomy treatment, air bubbles were noted in the tubing of the oad connection.Aspiration was performed to release the bubbles, however the patient status began to decline and imaging showed that air had been introduced into the lad.The oad and guide wire were removed and the patient entered cardiac arrest.The patient was stabilized and the procedure was completed without the use of the oad.The patient was in stable condition following the procedure.

• 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7629144
• MDR Text Key: 112025759
• Report Number: 3004742232-2018-00177
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)200331(10)221826
• 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: 06/22/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 221826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 75 YR