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

Model Number	DBP-175SOLID180
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2021
Type of Reportable Event	Serious Injury
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 (oad) was inserted into a tight, calcified superficial femoral artery.The oad was unable to pass through the lesion due to the severe calcium, and on the second attempt the oad sounded as though it was going to stall, however the device continued to spin.Treatment was stopped, and the crown was stuck in the lesion.The device was removed with some effort, and upon removal the tip bushing was missing and the driveshaft tip looked frayed.Imaging revealed there was no vessel damage.Additional review of angiography could not locate the missing fragment, and as the wire was discarded it could not be confirmed that the fragment was left on the wire.Balloon angioplasty and stent placement were performed to complete 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: 12309178
• Report Number: 3004742232-2021-00287
• Device Sequence Number: 17118782
• Product Code: MCW
• UDI-Device Identifier: 10850000491233
• UDI-Public: (01)10850000491233(17)10850000491233(10)359931-1
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/11/2021

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: 12/31/2022
• Device Model Number: DBP-175SOLID180
• Device Catalogue Number: 7-10057-07
• Device Lot Number: 359931-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2021
• Initial Report FDA Received Date: 08/11/2021
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 74