This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction or patient complication during the procedure.(b)(6) study (nanoknife-pancreatic cases): patient: (b)(6).Patient was already in hospital for jaundice related to bile duct stricture, patient had an ercp and a new stent placed during admission after developing a bile duct obstruction.Complaint investigation is warranted since the relationship to the study procedure is related to the device as assessed by the sae.This resulted in medical or surgical intervention to prevent permanent impairment to body structure or function.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
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As the reported nanoknife probe was not returned, angiodynamics is unable to perform a device evaluation.The reported complaint description of "patient had an ercp and a new stent placed during admission after developing a bile duct obstruction" could not be confirmed without a device evaluation.The root cause for this event cannot be determined.A device history review could not be performed as a catalogue number and a lot number were not provided.The instructions for use which is supplied to the end use, states: "warnings: do not use a device with damaged insulation.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.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".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.Complaint reference (b)(4).
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