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

Model Number DBP-EX-150CLA145

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The diamondback exchangeable orbital atherectomy device (oad) successfully performed treatment with a 2.00mm classic crown cartridge.The cartridge was exchanged for a 1.50mm classic crown cartridge.During testing, the oad would not turn off when the power button was pushed.The oad power cord was unplugged and re-plugged into the pump, and the issue recurred.The 1.50mm cartridge was replaced with the original 2.00mm cartridge, and when tested there were no issues observed.The oad was replaced with a non-exchangeable diamondback oad to complete the procedure.There were no patient complications and no major delays.

Manufacturer Narrative

The reported oad, 1.50mm classic crown cartridge and 2.00mm classic crown cartridge were received at csi for analysis.Visual examination did not reveal any damage.When tested, the oad spun on all speeds, and was powered on and off with both returned cartridges without any issues observed.The start switch and speed switch ribbons were both examined and did not reveal any damage that would have contributed to the reported event.While the oad was spinning, a saline solution was poured over the start switch, motor assembly and cable set.The oad continued to spin, and turn on and off as expected.The start switch was manually depressed with an increased amount of pressure, however the dome did not remain in the depressed state.Analysis of the data log download revealed that the start switch had a delayed response when the button was pushed, which could indicate to the operator that the device was non-responsive.At the conclusion of the device analysis, the reported event was confirmed through the data log.This was unable to be recreated during analysis, and the root cause could not be determined.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)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9856246
• MDR Text Key: 192188961
• Report Number: 3004742232-2020-00090
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491011
• UDI-Public: (01)10850000491011(17)211031(10)292758
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: DBP-EX-150CLA145
• Device Catalogue Number: 7-10031-10
• Device Lot Number: 292758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1