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

Model Number DBEC-125

Device Problems Pumping Stopped (1503); Complete Loss of Power (4015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id# (b)(4).

Event Description

During a procedure, the stealth saline infusion pump went into standby mode twice.The patient had been treated with five treatment passes prior to the issue.It was noted that all appropriate lights on the oad were lit when the device stopped spinning, and the pump had switched from a green to yellow light.It was confirmed that all connections between the pump, oad, and power source were secure.The procedure was aborted, and the patient was successfully treated with orbital atherectomy the following day.

Manufacturer Narrative

The reported oas pump and oad were received for analysis.No damage was visually observed either the pump or the oad.The pump was tested, and functioned as expected with no abnormalities observed.The oad would not spin on high or low speed when tested.Resistance was measured across the brake switch in the closed position and was high.The high level of resistance in the closed position can cause the device to not spin.At the conclusion of the device analysis, the reported event of the pump going into standby mode was unable to be confirmed, however, the oad spinning being stopped was confirmed.The aware date for csi that the oad was involved in the issue was 31-jan-2020.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.Csi id# (b)(6).

• 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
• MDR Report Key: 9610778
• MDR Text Key: 189336145
• Report Number: 3004742232-2020-00016
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70057-03
• Device Lot Number: 272213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 77