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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
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
The diamondback peripheral orbital atherectomy device would not flush properly and saline was not reaching the end of the device.No visible blockages were noted.The device was replaced to complete the procedure and no patient complications were reported.
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.When the oad was connected to the saline pump, no flow was observed through the handle assembly or saline sheath.Visual and destructive analysis of the oad nose cone fluid port found it to be blocked by adhesive.The nose cone assembly was cross sectioned, which revealed that the nose cone hypotube was not fully seated.This allowed adhesive to wick into the nose cone fluid port and block the flow of saline.There was no other damage or abnormalities observed with the device.Final functional testing of the oad performed prior to packaging includes an air flow test through the device.Devices that fail to meet these evaluations are discarded.At the conclusion of the device analysis investigation, the reported event was confirmed to be due to a manufacturing issue related to the nose cone hypotube.The device history record for this oad lot number has been reviewed.One oad from this lot was discarded due to a failure of the final functional air flow test.As devices that fail final functional testing are not retained, it is unknown if this was related to the findings of the reported device.(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; st. paul, mn MN 55112
• MDR Report Key: 8959479
• Report Number: 3004742232-2019-00235
• Device Sequence Number: 16788208
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)210331(10)261412
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/18/2019

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: 03/31/2021
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 261412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1