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

Model Number DBP-EX-200SOL145

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

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.The oad was returned to csi for analysis without the guide wire.Analysis of the driveshaft identified fractured filar protruding out of the saline sheath 49.2 cm proximal of the tip bushing which prevented the control knob from traversing.This confirmed the complaint of stuck control knob.Electron microscopic (sem) analysis of the driveshaft fracture revealed evidence of fatigue on the fractured filar face indicating that the failure occurred while spinning in the presence of a high-stress environment.It is hypothesized that a compressive force such as an introducer hemostasis valve or anatomical factor was applied to the saline sheath and the driveshaft presenting elevated stress resulting in the filar fracture, but the exact cause of the failure is undetermined.Review of the oad data log identified four stall events and over one and a half minutes of spin time.It is unknown if these events are related to the reported complaint.During evaluation, the oad spun as designed.Csi id: (b)(4).

Event Description

During treatment of a heavily calcified, 70% stenosed lesion in the superficial femoral artery (sfa), the diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was powered on to begin treatment, but the control knob felt stiff/stuck.The vessel was 7mm in diameter.Troubleshooting steps were taken but the issue persisted.A new oad and the same viperwire advance guide wire were used to complete the procedure.The patient was stable and did not experience impact.After receiving the returned oad, analysis revealed a driveshaft filar had been fractured within the oad saline sheath.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18667821
• MDR Text Key: 336215239
• Report Number: 3004742232-2024-00102
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-EX-200SOL145
• Device Lot Number: 498930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial