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

Model Number	DBE-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Code Available (3191)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the device became stuck in the lesion.The target lesion was 90% stenosed and located in the distal pedal artery.Following one pass of the oad on low speed, the device became stuck in the vessel.The oad was cut at the nose cone and a non-csi exchange catheter was inserted around the crown to remove the device.Removal of the device resulted in a one hour procedural delay.No additional treatment was performed on the initial lesion due to vessel spasm.Balloon angioplasty was performed on a second lesion in the lateral plantar area and the patient was in stable condition following the procedure.

• 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: 7763989
• Report Number: 3004742232-2018-00242
• Device Sequence Number: 1204497
• Product Code: MCW
• UDI-Device Identifier: 10852528005015
• UDI-Public: (01)10852528005015(17)210331(10)219300
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: DBE-150
• Device Catalogue Number: 70056-01
• Device Lot Number: 219300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR