(b)(4).Failure analysis conclusion: the device was received at csi for investigation without the guide wire.Shipping damage was observed and removed to allow for functional testing.An in-house test wire was passed through the device without issue.There was no other damage observed with the oad.When tested, the device functioned as intended.At the conclusion of the failure analysis investigation the reported possible spasm and embolism were not confirmed.There was no damage or abnormalities observed with the oad or driveshaft that would have contributed to the reported complaint.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 diamondback360® peripheral orbital atherectomy system instructions for use manual states that distal embolization and vessel spasm are adverse events that can occur during use of the device.(b)(4).
|
Atherectomy was performed on low, medium, and high speeds with a diamondback peripheral orbital atherectomy device.The treatments were performed in the popliteal artery.A stent was placed with good angiographic result.Imaging showed possible spasm and embolization in the posterior tibial (pt) artery.Attempts to rewire the vessel with a non-csi wire caused a complication in the pt artery.This complication was not caused by csi product.The complication was not treated; the patient was monitored.The patient had an observable pulse in the pt artery on ultrasound and was discharged on (b)(6) 2019.
|