MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ventricular Tachycardia (2132)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).Device unavailable for return.

Event Description

As reported (b)(6) 2016, a (b)(6) year old, male patient presented for an ire (irreversible electroporation) procedure of the liver.The nanoknife probes were placed in the patient by the physician with no issues.The physician "ssarted" 20 pulse tissue conductivity test, pulse length 90, when the patient went into complete supraventricular tachycardia.The physician aborted the pulse delivery and the anesthesist medicated the patient.The physician tried 20 pulses again, but, heart rate was still high, 10 pulses in, at which time physician determined to abort the pulse delivery and treatment.Probes were removed.It was reported the patient was stable post procedure.It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect during an ire procedure using an angiodynamics' device.There was no report of a device malfunction during the ire procedure.As the device associated with the adverse event was not returned, angiodynamics is unable to perform a device evaluation.The customers reported complaint of the patient experiencing 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.It was reported that the case was aborted and the patient is stable.A definitive root cause for this event cannot be determined, although tachycardia is a known potential effect of the procedure.A review of the lot history records, obtained via shr, 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 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".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).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6241954
• MDR Text Key: 64508031
• Report Number: 1319211-2017-00004
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR