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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results - reported event not confirmed.The reported oad was received for analysis.Upon visual examination, the driveshaft was found to have overloading damage, which is consistent with the device experiencing some form of resistance while spinning.The cause of the damage could not be determined.When tested, the oad would not spin.After continuous pressure was applied to the brake lever, the oad spun as intended on all speeds.Analysis of the brake assembly found two securing screws which were not fully seated, preventing the brake lever from engaging the brake switch.This was determined to be unrelated to the reported event, as the device is unable to spin if the brake switch is not engaged.At the conclusion of the device analysis investigation, the reported event was unable to be confirmed.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).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a device malfunction occurred.The peripheral device was intermittently turning on outside of operator control prior to insertion into the patient.The device was replaced and the procedure was completed with no consequences to the patient.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7667039
• Report Number: 3004742232-2018-00197
• Device Sequence Number: 13948162
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)200331(10)219850
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/06/2018

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: 03/31/2020
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 219850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1