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

Model Number	DBE-150
Medical Device Problem Codes	Infusion or Flow Problem (2964); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was received at csi for analysis.Visual examination revealed embedded, dried biological material under the crown and between the crown and tip bushing section.Biological fluid buildup was also observed in the saline sheath.The biological material accumulation prevented a guide wire from passing through the device.Further examination of the oad did not reveal any damage that would have contributed to the accumulation.The root cause of the accumulated material could not be determined.The oad was tested on all three speeds with no unusual noises observed.As the original saline line was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.At the conclusion of the device analysis, the reported event that the oad made an unusual noise and blood backed up into the saline tubing was partially confirmed.There was biological accumulation observed, however the oad functioned as intended when tested.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).
Event or Problem Description
The peripheral stealth orbital atherectomy device (oad) made an unusual sound when it was activated to perform treatment, and blood backed up into the saline tubing.The oad was removed from the patient and replaced with a second device to complete the procedure.There were no patient complications.The target lesion was located in the mid to distal side of the superficial femoral artery (sfa) and was 100 millimeters in length with moderate calcification.
Additional Manufacturer Narrative
Corrected fields: h6 - results code was updated from 114 to 4247.Results code 4247: biological material present.

• 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: 8937270
• Report Number: 3004742232-2019-00227
• Device Sequence Number: 11273213
• Product Code: MCW
• UDI-Device Identifier: 10852528005015
• UDI-Public: (01)10852528005015(17)220531(10)272819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/28/2019

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: 05/31/2022
• Device Model Number: DBE-150
• Device Catalogue Number: 70056-01
• Device Lot Number: 272819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1