During treatment in the distal anterior tibial artery and dorsalis pedis arteries, the stealth 360 peripheral orbital atherectomy device (oad) stalled while in the mid dorsalis pedis artery.The patient experiences restless leg syndrome and when intravascular ultrasound was employed, the vessel spasmed.When the oad was removed, a medial and inferior perforation of the dorsalis pedis artery was observed.Angioplasty was performed and left in place for 2 minutes to tamponade the vessel.Final angioplasty revealed a perforation was still present.The procedure was completed and, compression dressing was placed on access site on foot.
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The oad was received at csi for analysis.Review of the oad's data log, confirmed the reported stall.The root cause of the stall events was not determined.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 diamondback 360® peripheral orbital atherectomy system instructions for use manual states that perforation and vessel spasm are potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(4).
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