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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.The saline sheath was observed to be separated at the nose cone and the nose cone was damaged and deformed.This damage was suspected to be related to shipping as the device was returned without protective packaging.The damaged section was removed and the fluid was injected through the handle assembly.The fluid was noted to exit the nose cone glue plug area within the handle assembly as expected, and no abnormal leaking was observed.There was no damage to the shaft, sheath or saline path that would indicate that limited flow may have occurred.After continuing to add saline to the device during analysis, fluid began to leak out of the proximal foot, including near the power cord.This is not unusual as the device handle is not designed to hold unlimited amounts of liquid, and it is not an indication that saline is not flowing through the device.After extended use, fluid can build up within the handle assembly and leak due to overflow or when the handle is tilted.When the oad was tested for functionality, it functioned as intended.At the conclusion of the device analysis investigation, the reports of the device leaking and saline not reaching the tip of the device were not 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).
Event or Problem Description
The peripheral orbital atherectomy device was noted to be leaking from the black power cable after treatment began.There was concern on the part of the physician that not enough viperslide was being delivered to the patient.The procedure was completed with the device and there were no patient complications reported.

• 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; st. paul, mn MN 55112
• MDR Report Key: 9266991
• Report Number: 3004742232-2019-00284
• Device Sequence Number: 2616371
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210531(10)274138
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 11/01/2019

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: 05/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 274138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 85