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

Model Number	PRD-SC30-125
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a device malfunction occurred.During preparation for the procedure, it was noted that the saline solution would not advance through the tubing of the peripheral device.The procedure was completed with balloon angioplasty and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported oad was received for analysis.When the device was tested for functionality, there was no fluid flow observed through the saline line.Examination of the saline line revealed an adhesive occlusion in the saline hose barb connector on the hose junction.There were no other issues observed with the device.At the conclusion of the device analysis investigation, the reported event was 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.(b)(4).

• 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: 7973603
• Report Number: 3004742232-2018-00308
• Device Sequence Number: 1773755
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)191031(10)173425
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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): 11/02/2018

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: 10/30/2019
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 70056-03
• Device Lot Number: 173425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Age: 73 YR