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

Model Number 20300101

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

As there was no report of a device malfunction, the customer has determined not to return the unit to the manufacturer for assessment at this time.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.A review of the device history records was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.Complaint # (b)(4).

Event Description

As reported on (b)(6) 2015, a (b)(6) patient of unknown gender, had underwent a nanoknife procedure of the pancreas on (b)(6) 2015.During the procedure the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors.It was reported that on (b)(6) 2015, a follow up ct scan performed on the patient showed a celiac artery thrombosis.It was reported the patient was asymptomatic.The celiac artery was within the treatment zone, and it was determined no further medical intervention was required to treat the thrombus.It was reported the patient was doing well.The customer has determined not to return the nanoknife system for evaluation to the manufacturer for assessment as there was no report of malfunction of the unit.

Manufacturer Narrative

This report is not to report a device malfunction, but a patient response to the procedure.The nanoknife system was not returned to angiodynamics for evaluation and repair.The unit had functioned as intended.Based on information provided by the user, the customer's reported complaint description is confirmed.Although the reported complaint description is confirmed, a definitive root cause cannot be determine.However, thrombosis is a known procedural complication and listed in the nanoknife user manual, provided with this unit to the customer.The nanoknife generator user manual (160-105261 rev 01) contains the following warnings "additional 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)." as anticipated with a needle-related procedure, repeated vascular insult due to multiple insertions into a vessel by an electrode during electrode placement may cause thrombus.Potential adverse effects - venous thrombosis".A review of the device history records was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).Device was retained by user.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5070414
• MDR Text Key: 25616220
• Report Number: 1319211-2015-00334
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR