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

Device Problems Loss of Power (1475); Insufficient Information (3190)

Patient Problems Thrombosis (2100); No Information (3190)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

The single use nanoknife probes used during the event were disposed of and not available for evaluation.In lieu of a reported item number of lot number, a ship history report (shr) was generated for all single use nanoknife probes in order to ascertain the last three manufacturing lots numbers shipped to the reporting customer in the six months prior to the procedure date.The lot records and the certificate of compliance were reviewed for the manufacturing lot numbers obtained through the shr.The review confirmed that the packaging lots and all component lots met all material, assembly, and performances specification.On (b)(6) 2015, an angiodynamics hardware service engineer performed a field assessment on the unit.No issues or defects were noted.The unit functioned as intended during testing.Angiodynamics is attempting to obtain further information including pt's medical history and location of the treatment area to the superior mesenteric artery.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).

Event Description

As reported on (b)(6) 2015, a (b)(6), female presented for a nanoknife procedure of the pancreas on (b)(6) 2015.During the procedure the generator shut down.The physician was able to reboot the generator and successfully complete the procedure without further issue.Just before procedure close, thrombosis of superior mesenteric artery was noted.Thrombosis managed via additional surgery however the pt was hospitalized for approx.Two weeks post procedure.As of (b)(6) 2015, the pt is stable and has suffered no lasting or permanent harm due to the event.

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 during the procedure.Although the unit had functioned as intended, as a precautionary measure, an angiodynamics' hardware service engineer performed a field assessment on the unit.No issues or defects were noted.The unit functioned as intended during nanoknife operation verification.The disposable probe used during the procedure was not returned for a device evaluation.Angiodynamics' supplier was informed of the event.The supplier performed a lot history review and determined the device met all material, assembly, and performance specifications prior to distribution.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 nanoknife system 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: 5094785
• MDR Text Key: 26485068
• Report Number: 1319211-2015-00336
• 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: Other
• Type of Report: Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• 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: 59 YR