MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	DBP¿150CLASS145
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was using the diamondback 360 peripheral orbital atherectomy system, the device was operating as intended at low and medium speed.When physician switched to high speed the device failed to increase speed.No adverse effect on patient.Manufacturer response for catheter, peripheral, atherectomy, diamondback peripheral (per site reporter).Company vendor made aware and will be picking product up for evaluation.

• Brand Name: DIAMONDBACK PERIPHERAL
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 14740 kirby dr.; houston TX 77047
• MDR Report Key: 7262928
• Report Number: 7262928
• Device Sequence Number: 763850
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)191031(10)206397
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018
• Report Date (Section F): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: DBP¿150CLASS145
• Device Catalogue Number: DBP¿150CLASS145
• Device Lot Number: 206397
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2018
• 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
• Date Report Sent to FDA: 02/07/2018