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

Model Number DBEC-125

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

During set-up for a procedure with a saline infusion pump and a diamondback coronary orbital atherectomy device (oad), the site reported that it sounded like the pump/oad was priming without the prime button being pressed.When a csi clinical specialist tested the oad and pump, it seemed like the viperslide solution may have been coming out of the tip faster than normal, but it this was unable to be confirmed.It was noted that the pump sounded like it was running at the correct speed at normal rate and priming rate.The physician had not previously encountered this issue with the saline pump used in the procedure and felt like it was likely the oad that had a malfunction.The procedure was not completed.The procedure was successfully rescheduled and completed on (b)(6) 2019.

Manufacturer Narrative

Failure analysis conclusion: the saline pump was received at csi for investigation.The saline pump motor was tested for functionality and run for a total run time of 45 minutes at high speed without any issues or abnormal sounds observed.The primer button was tested and functioned as intended.The pump flow rate was also tested and met specifications.At the conclusion of the failure analysis investigation the reported priming and flow rate events could not be confirmed.As the original oad was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.The device history record for this pump 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: 8596532
• MDR Text Key: 144595114
• Report Number: 3004742232-2019-00124
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210131(10)255130
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 255130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 102