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

Model Number	DBP-200CLASS145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis.Upon visual examination, the driveshaft was observed to be damaged and severely stretched.The crown was confirmed to be detached and was not received for analysis.Scanning electron microscopy analysis of the driveshaft crown bond location confirmed the presence of residual solder, which indicated that the crown had been sufficiently attached at one point.It is hypothesized that the crown became stuck and the driveshaft was pulled until it exceeded the bond strength of the crown, causing the detachment.This is consistent with the reported details which state "the physician pulled on the oad and the crown was observed to detach in the anterior tibial artery." however, this was not confirmed, and the exact root cause of the detached crown could not be determined.When tested, the oad was found to have functioned as intended.At the conclusion of the device analysis investigation, the report that the crown of the oad detached was confirmed.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).
Event or Problem Description
When treatment with the diamondback peripheral orbital atherectomy device (oad) was completed, the device would not move during removal attempts.The physician pulled on the oad and the crown was observed to detach in the anterior tibial artery.The crown was removed using a snare and the patient was in stable condition post-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; st. paul, mn MN 55112
• MDR Report Key: 11835308
• Report Number: 3004742232-2021-00179
• Device Sequence Number: 4443662
• Product Code: MCW
• UDI-Device Identifier: 10850000491257
• UDI-Public: (01)10850000491257(17)220531(10)327566
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/17/2021

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-200CLASS145
• Device Catalogue Number: 7-10057-09
• Device Lot Number: 327566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/17/2021
• 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