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

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned with a driveshaft fracture on the distal side of the crown along with a single filar fracture on the proximal side of the crown.Scanning electron microscopic (sem) analysis identified possible fatigue striations at the site of the driveshaft fracture.It is possible the driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.The diamondback 360 coronary orbital atherectomy device instructions for use states the following warnings: "performing treatment in excessively tortuous or angulated vessels or bifurcations may result in vessel damage or device failure requiring retrieval" and "never use force to advance the spinning crown as vessel perforation may occur.If any resistance to crown travel is felt, reposition the crown away from the lesion, immediately stop treatment, and use fluoroscopy to assess the vessel for any complications".However, the exact root cause could not be conclusively determined.When tested, the oad functioned as intended.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.Csi id: (b)(4).
Event or Problem Description
During treatment with the diamondback 360 coronary orbital atherectomy device (oad) on a calcified and tortuous right coronary artery (rca), the crown fractured from the nose cone.The fracture occurred after the fifth low speed treatment was performed.A parallel wire was used to retrieve the oad and viperwire advance guide wire.No components remained in the patient.A high-pressure balloon and intravascular lithotripsy (ivl) were performed, followed by a stent placement to complete the procedure.The patient was discharged the following day and in stable condition.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19014206
• Report Number: 3004742232-2024-00151
• Device Sequence Number: 8156446
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)251130(10)515389-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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: 11/30/2025
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 515389-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male