The reported saline pump was returned for analysis with the diamondback peripheral orbital atherectomy device (oad) and viperwire guide wire utilized during the procedure.A visual analysis did not reveal any damage to any of the devices.The pump was activated and tested at both low and high speeds.The pump operated as intended during all functions and no anomalies were noted.The oad was examined and there was no damage to the saline line, nose cone assembly, or other components which may have contributed to the reported event.The oad was connected to the saline pump and saline line, and fluid was infused through the handle assembly, saline sheath and driveshaft with no issue.At the conclusion of the device analysis investigation, the reported event was unable to be confirmed and the root cause is unknown.All returned components functioned as intended.The device history records for these devices have been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The devices met material, assembly, and quality control requirements prior to distribution.(b)(4).
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During treatment of a lesion with a diamondback peripheral orbital atherectomy device (oad), blood was observed flowing back into the device.The blood was unable to be flushed from the device using the saline pump.A second pump was used and functioned without issue, and the procedure was completed with the original oad.There were no patient complications reported.
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