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

Model Number DBEC-125

Device Problems Failure to Power Up (1476); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported oad was received for analysis.When tested, the device functioned as intended with no anomalies noted.However, detailed analysis revealed the crown to be detached and missing from the driveshaft.Scanning electron microscopy was performed and revealed weld nuggets remaining on the driveshaft after the crown detachment, indicating a good weld.There was no other damage or abnormalities with the device or its components that would have contributed to the reported event.At the conclusion of the device analysis investigation, the reported event was unable to be confirmed, and the cause of the crown detachment could not be conclusively determined.(b)(4).

Event Description

During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), the device would not power on.When the oad was loaded over the guide wire, it would not power on during the pre-procedure check prior to insertion into the patient.The device was replaced and the procedure was completed with no consequences to the patient.Upon analysis of the reported device, the crown was noted to be detached.

• 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: 7396381
• MDR Text Key: 104716625
• Report Number: 3004742232-2018-00090
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)191130(10)208371
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 208371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• 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