Proximal to distal treatment with a diamondback peripheral orbital atherectomy device (oad) was performed in the peroneal artery.Imaging showed vessel spasm, but treatment was continued.The device stalled and became stuck in the artery.The physician then attempted to remove the device, and the driveshaft fractured on the proximal edge of the crown.The patient was sent to surgery for removal of the fragment.The patient made a full recovery following surgery.In the opinion of the physician, the crown selected was too large for the vessel, and oa should not have been used during spasm.
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Device evaluation conclusion: the oad was received at csi for analysis.Visual examination revealed the driveshaft filars were stretched and deformed.A fracture was also observed.The distal fractured crown section of the oad was not returned for analysis.The fractured filars were sent for scanning electron microscopy (sem) analysis, which showed evidence of torsion and stretching.It is hypothesized that the driveshaft fractured due to tensile forces that occurred during removal attempts.Details reported to csi indicated, the opinion of the physician was that the crown selected may have been too large for the vessel, and oa should not have been used during spasm.Therefore, the root cause of the reported complaint is considered to be user error.At the conclusion of the device analysis investigation, the reported stall and entrapment of the oad in the vessel could not be confirmed through analysis.The reported driveshaft fracture was confirmed through analysis.The diamondback 360® peripheral orbital atherectomy system instructions for use manual states, "do not use the device in a vessel that is too small for the crown," and, "do not use device during spasm of the vessel.".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.A complaint was reported related to a viperwire used in this procedure.That event has been captured in mdr 3004742232-2020-00376.Csi id: (b)(4).
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