Using the diamondback 360 peripheral orbital atherectomy device (oad), atherectomy treatment in the distal perineal which was moderately calcified was performed proximal to distal.Low, medium and high speed were used and while using high speed the crown became entrapped in the vessel.The oad was not able to be advanced proximally out of the vessel.Using the advancer knob, unsuccessful attempts were made to remove the device.The physician manually pulled on the driveshaft, causing it to fray.The physician then cut the driveshaft and removed the oad.The portion of the driveshaft that was cut, including the crown, remained in the popliteal causing an arteriovenous fistula.The procedure lasted approximately seven hours while attempting to remove the crown.The patient underwent amputation.
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The diamondback coronary orbital atherectomy device (oad) was returned to csi for analysis.The oad drive shaft was severely stretched and separated in two locations.Analysis of the portions of the device that were returned did not identify any damage or abnormalities that would have contributed to the reported complaints.Based on the analysis and reported complaint, the damaged drive shaft is likely due to troubleshooting and removal attempts after the oad became stuck.The root cause of the failure is undetermined.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).
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