The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively 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.Csi id# (b)(4).
|
A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a 80-90% stenosed lesion in the dorsalis pedis accessed via a dorsalis pedis access.The lesion was moderately to severely calcified.The vessel was 2.0-2.5mm in diameter and moderately tortuous.The lesion was wired, and, during the second treatment, the oad stalled, and the oad was pulled back quickly.It was suspected that the vessel spasmed, which led to the device becoming stuck in the vessel.The lesion was treated with balloon angioplasty for three minutes.Angiography was performed, and a perforation was observed proximal to where the crown seized.Additional balloon angioplasty was performed for greater than 15 minutes.Imaging revealed residual extravasation, and an external hemostasis device was applied.The patient was stable following the procedure.It was unknown if the oad caused or contributed to the perforation.
|