The diamondback peripheral orbital atherectomy device (oad) could not be advanced via common femoral access to the target lesion in the superficial femoral artery, which was heavily calcified.The iliac bifurcation was tortuous, and difficulty was experienced in advancing the oad across it.The oad was being used with a 6fr 45cm guide catheter.The oad was removed, and the guide catheter was replaced with a 7fr catheter.At that time, it was noted the distal driveshaft and crown had fractured on the proximal edge of the crown.The fragment was snared.Directional atherectomy was used to complete the procedure.
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Device analysis conclusion: the oad was received at csi for analysis.Visual examination confirmed the reported fracture.Scanning electron microscopy analysis identified evidence of fatigue failure on the fractured filar faces.The device data log shows that the device was spun several times.Two of the spins resulted in stalls.It is hypothesized that the oad was spun past a tight bend, which resulted in the fatigue fracture.However, this could not be conclusively confirmed, and the root cause of the fracture remains undetermined.The oad functioned as intended during testing.The device history record for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event and the device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).
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