Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a truepath device.The control unit, motor housing and working length and tip/tip housing were microscopically examined.There was foreign matter, fibers, wrapped around the tip.There is saline along the shaft and the tip.The device was soaked and the foreign matter was removed.There was no other visible damage or irregularities.Functional testing was performed on the device.When the device was turned on the alert mode was on and the outer shaft rotates with the tip.The device was taken apart and the collet was loosened and removed, no damage or abnormalities were present.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).
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Reportable based on device analysis completed on 23-feb-2018.It was reported that the tip failed to rotate.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A truepath¿ cto device was selected for use.During the procedure, when the device was inserted inside the patient's body, it was noted that the tip of the truepath¿ device stopped rotating.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that there were fibers wrapped around the tip and the outer shaft rotates with the tip.
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