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

Model Number	DBP-150CLASS145
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted after the device analysis is completed.(b)(4).
Event or Problem Description
The diamondback peripheral orbital atherectomy device (oad) reportedly shut down and started back up without the user prompting it to.A second oad was used to complete the procedure without significant delay and without any further issue.
Additional Manufacturer Narrative
At the conclusion of the failure analysis investigation the event could not be confirmed through analysis.The device did not shut down or start up without prompting during functional testing.It should be noted that if a spinning driveshaft is brought to a stall condition and remains stalled for 3 seconds, the device will acknowledge a stall condition and stop attempting to spin.However, if a spinning driveshaft is brought to a stall and is freed up within 3 seconds, the driveshaft may resume spinning.It is possible that the device became temporarily stalled during the procedure and then the crown became freed up within 3 seconds, resulting in the device spinning again and appearing to start up by itself.Detailed analysis did not reveal any damage that would have contributed to the reported complaint.Analysis did reveal some adhered biological material on the driveshaft and crown, however it could not be determined if the material contributed to the reported complaint 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).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8020330
• Report Number: 3004742232-2018-00324
• Device Sequence Number: 1381990
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)200831(10)236267
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: DBP¿150CLASS145
• Device Lot Number: 236267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1