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

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was discarded and not returned for analysis.While the details reported to csi indicate that the device was pulled on by the user, the device could not be analyzed to verify this was the cause of the reported entrapment and fracture.Based on the information received, the cause of the reported event could not be conclusively determined.(b)(4).
Event or Problem Description
Two treatments were administered in the right iliac artery using a diamondback pluto peripheral orbital atherectomy device (oad).When the device was activated for a third treatment, it stalled and could not be removed.The physician pulled on the device, and the driveshaft fractured on the proximal side of the crown.Additional access was obtained to snare the fragment.The procedure was completed with stent placement and without further issue.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11156531
• Report Number: 3004742232-2021-00004
• Device Sequence Number: 17173114
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)220531(10)328726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 05/31/2022
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 328726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/12/2021
• 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