As there was no indication of malfunction of either the disposable device or the nanoknife unit, neither device was returned for evaluation.The customers reported complaint of the patient experiencing v-tach (tachycardia) could not be confirmed because no sample was returned for evaluation.Additionally, due to the nature of this complaint, functional testing of a returned sample would not duplicate the issue due to the root cause being a patient issue.There was no report of device malfunction or performance problems.A review of the lot history records, obtained via a ship history review, was performed for the nanoknife probe lots any deviation in manufacturing process related to the reported defect of the complaint.The review confirmed that the lot and the associated components used within the lot all conformed to manufacturing processes and testing.The ifu lists tachycardia as a potential effect of the procedure.The case was aborted and the patient is stable.The instructions for use, which is supplied to the end user with this catalog number, states: "adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial, fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, fistula formation, damage to critical anatomical structure (nerve, vessel, duct), hematoma, hemorrhage, hemothorax, infection, muscle contraction pneumothorax , reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis".The nanoknife generator user manual states that patients may be at risk with insufficient muscle blockade or anesthetic analgesia (reflex tachycardia and reflex hypertension); patients with abnormal sinus rhythm prior to an ablation (arrhythmia); patients with a history of hypertension (hypertension); or patients with partial portal venous thrombosis, low central venous pressure (cvp), and a prothrombotic condition (venous thrombosis).A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).
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As reported to angiodynamics on july 24, 2017: during an ire procedure of the liver, the patient experienced v-tach.The procedure was aborted, at which time, the patient resumed normal rhythm.This medwatch is not to report a device malfunction, but to report an adverse patient effect.It was reported the disposable device will not be returned to the manufacturer for evaluation.The medical facility determined not to return the unit to angiodynamics for assessment as the unit functioned as intended.
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