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

Model Number	RAD-SC30-125
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
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.Csi id# (b)(4).
Event or Problem Description
Following treatment of a calcified lesion with a csi diamondback peripheral orbital atherectomy device (oad), the shaft of the device was noted to contain blood.The device was examined and it was verified that no saline was flowing through the shaft.It is unknown how long the device was operated without saline flow.There was no injury to the patient reported.
Additional Manufacturer Narrative
The reported oad was received for analysis without the saline line or guide wire.A visual observation identified dried biological fluid in the handle assembly and saline sheath.The handle, saline line and nose cone assemblies were examined and found to be undamaged and intact.Water was flushed through the handle assembly with a syringe and was found to flow through the handle assembly, saline sheath and driveshaft without issue.As the original saline line was not returned for analysis it could not be determined if it contributed to the reported event.At the conclusion of the device analysis investigation, the device was found to function as intended with no anomalies noted.The report that saline was not flowing through the device 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 prior to distribution.Csi id# (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: 8246224
• Report Number: 3004742232-2019-00025
• Device Sequence Number: 2575297
• Product Code: MCW
• UDI-Device Identifier: 10852528005756
• UDI-Public: (01)10852528005756(17)200831(10)236145
• 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): 01/22/2019

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: RAD-SC30-125
• Device Catalogue Number: 7-10058-01
• Device Lot Number: 236145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1